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Lower risk Medical device recall · FDA · Published September 5, 2025

Philips S5-1 Ultrasound Transducer Recall: Clarification on Useful Life

Philips recalls S5-2 ultrasound transducers for labeling clarity on useful life. This update helps users understand expected service duration without safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1626-2026Medical devicePhilips ›
Take action

Contact the company

Recalling firmPhilips Ultrasound, Inc1 Echo Dr · Reedsville, PA 17084-8603
✎ GovInfoNow plain-language explainer

Philips is recalling its S5-2 ultrasound transducers to improve labeling about their expected useful life in clinical use. This recall helps healthcare providers better manage device maintenance and replacement schedules. Read more at govinfonow.com/recall/51419-philips-s5-1-ultrasound-transducer-recall-clarification-on-useful-life.

Source Summary by GovInfoNow · govinfonow.com/recall/51419-philips-s5-1-ultrasound-transducer-recall-clarification-on-useful-life · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1626-2026

Cite this page

“Philips S5-1 Ultrasound Transducer Recall: Clarification on Useful Life.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51419-philips-s5-1-ultrasound-transducer-recall-clarification-on-useful-life. Based on FDA recall #Z-1626-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1626-2026%22&limit=1).

Philips Ultrasound, Inc. recalled its Philips S5-2 Ultrasound Transducer on Sept. 5, 2025, to clarify labeling defining the device's useful life, according to the FDA. The Food and Drug Administration announced the voluntary Class III recall.

How to tell if you have it

  • Philips S5-2 Ultrasound Transducer
  • Model No. 989605368393
  • UPC 00884838064638

The hazard

The recall addresses the need to provide clarification and labeling to define the useful life of ultrasound transducers in the field.

Context

GovInfoNow's records show Philips Ultrasound, Inc. has issued 14 other recalls since April 29, 2019. Recent similar actions include a July 3, 2025 recall for labeling clarification and a May 28, 2025 recall regarding transducers refurbished beyond their useful life. Other recent recalls of similar products include the HiResolution Bionic Ear System Recall (April 30, 2026) and the Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026).

How to tell if you have this one

Check for the model number 989605368393 or serial number B0C824 on the transducer. These devices were sold with specific labeling for field use.

  • Brand
    Philips
  • Product
    Philips S5-2 Ultrasound Transducer
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1618-2026Philips 3D6-2 Ultrasound Transducer; Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.17 units
Z-1619-2026Philips C9-4 Ultrasound Transducer; Model No. 989605365021; UDI: N/A; Serial No. 033DZ4.1 unit
Z-1620-2026Philips L12-5 Ultrasound Transducer; Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB.40 units
Z-1621-2026Philips L17-5 Ultrasound Transducer; Model No. 989605366371, 989605388061; UDI: N/A; Serial No. 03228X, 03360Q.2 units
Z-1622-2026Philips Mini Multi TEE Ultrasound Transducer; Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.11 units
Z-1623-2026Philips OMNI II TEE Ultrasound Transducer; Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.2 units
Z-1624-2026Philips OMNI III TEE Ultrasound Transducer; Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0, (01)00884838067585(21)039Q2L, (01)00884838067585(21)02YCFD, (01)00884838067585(21)B05DX2, (01)00884838067585(21)02WCTB, (01)00884838067585(21)039PC3, (01)00884838067585(21)035V3H, (01)00884838067585(21)038DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)02CGWH, (01)00884838067585(21)032MLN, (01)00884838067585(21)038LT2, (01)00884838067585(21)03G4GG, (01)00884838067585(21)03435X, (01)00884838067585(21)032MMK, (01)00884838067585(21)B0JFDK, (01)00884838067585(21)02WMD4, (01)00884838067585(21)02JP4Z, (01)00884838067585(21)031LCH, (01)00884838067585(21)02JJ6T, (01)00884838067585(21)039JWV, (01)00884838067585(21)035YQG, (01)00884838067585(21)03C04R, (01)00884838067585(21)02DCH7, (01)00884838067585(21)02D9TH, (01)00884838067585(21)035Q9M, (01)00884838067585(21)031CDK, (01)00884838067585(21)0379BH; Serial No. 02ZTTT, 02DFBP, B0X7MD, 039MMD, 02VWNV, 02JQPG, 02PCMT, 0341PG, 02GR5B, 035PWZ, 02QLMQ, B0JFCN, 03CVTB, 03C009, 02Y7HM, 02VTGK, 037CHG, 03G0BB, 02WH6F, 02QK2L, 038MJ6, 037F68, 038GL7, 0344C9, 037HLM, 035R8K, 02JL01, 02JJ0T, 031LC8, 039JWQ, 035PYK, 03436F, 039PCB, 031HN7, 02P8GV, 039HQ2, B07FFB, 03F770, 035Q9P, 0319LX, 02DG0D, B0JF93, 03C7Q0, 039Q2L, 02YCFD, B05DX2, 02WCTB, 039PC3, 035V3H, 038DX2, B0LYR8, 02CGWH, 032MLN, 035P8R, 038LT2, 03G4GG, 03435X, 032MMK, 02QGKV, B0JFDK, 02VN40, 032FKW, 02WMD4, 02JP4Z, 031LCH, 02JJ6T, 039JWV, 035YQG, 03C04R, 03C6ZH, 02DCH7, 02D9TH, 035Q9M, 031CDK, 0379BH.75 units
Z-1625-2026Philips S4-1 Ultrasound Transducer; Model No. 989605458221, 989605458222, 989605477101; UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK, (01)00884838085183(21)B25VX0, (01)00884838085183(21)B21Y07, (01)00884838085183(21)B21Y6L, (01)00884838085183(21)B21XYW, (01)00884838085183(21)B1RCNL, (01)00884838074231(21)B21Y64, (01)00884838074231(21)B21YF6, (01)00884838085183(21)B2D34Z, (01)00884838085183(21)B1RCVN, (01)00884838085183(21)B1W8DH, (01)00884838085183(21)B21XTP, (01)00884838085183(21)B21XXQ, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.41 units
Z-1626-2026Philips S5-2 Ultrasound Transducer; Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.1 unit
Z-1627-2026Philips X3-1 Ultrasound Transducer; Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.17 units
Z-1628-2026Philips X7-2 Ultrasound Transducer; Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.5 units
Based on the official FDA remedy

What to do — step by step

  1. Review Labeling

    Check the transducer's labeling for updated useful life information to ensure proper maintenance.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 7 months after the firm started it.

1. Firm started the recall: Sep 5, 202512. FDA classified it Class III: Mar 24, 202623. Published in FDA’s Enforcement Report: Apr 1, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1626-2026 (September 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1626-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA