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Use caution Medical device recall · FDA · Published February 24, 2021

Philips CT Systems Recall: Incisive Couch May Fail to Lock

Philips Healthcare recalls CT systems with Incisive CT couch that may fail to self-lock, causing unexpected downward movement. Affected units have specific Unique Device Identifiers.

🇺🇸 FDA recall #Z-1273-2021Medical devicePhilips Healthcare ›
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Recalling firmPhilips Healthcare (Suzhou) Co., Ltd.Suzhou Industrial Park, No. 258 Zhongyuan Road · Suzhou, China
✎ GovInfoNow plain-language explainer

Philips Healthcare is recalling certain CT systems that use an Incisive CT couch. The couch may fail to self-lock and move unexpectedly downward, which could cause injury during medical procedures. Read more at govinfonow.com/recall/63240-philips-ct-systems-recall-incisive-couch-may-fail-to-lock.

Source Summary by GovInfoNow · govinfonow.com/recall/63240-philips-ct-systems-recall-incisive-couch-may-fail-to-lock · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1273-2021

Cite this page

“Philips CT Systems Recall: Incisive Couch May Fail to Lock.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63240-philips-ct-systems-recall-incisive-couch-may-fail-to-lock. Based on FDA recall #Z-1273-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1273-2021%22&limit=1).

The FDA announced on Feb. 24, 2021, that Philips Healthcare (Suzhou) Co., Ltd. is recalling 109 Philips CT systems due to actuators that may fail to self-lock. This defect could cause the patient couch to unexpectedly move downward. Owners should contact Philips for repair instructions.

How to tell if you have it

  • Brand: Philips Healthcare
  • Product: Philips CT systems
  • UPC: 00884838059849
  • UPC: 00884838085015

The hazard

Philips detected an issue with the actuators in the Incisive CT couch that could prevent it from self-locking. This failure may cause the couch to move slowly downward to its limit position unexpectedly.

Context

GovInfoNow's records show Philips Healthcare (Suzhou) Co., Ltd. has had 3 other recalls since 2022-12-23. Other recent recalls of similar products include the Philips Incisive CT Software V4.5/V5.0 Recall on 2026-06-26 and the Philips Azurion 7 B20 System Recall on 2026-01-26.

How to tell if you have this one

Check for the Unique Device Identifiers listed in the recall notice. Affected units have specific codes starting with (01)00884838085015(21) followed by numbers.

  • Brand
    Philips Healthcare
  • Product
    Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Recalled Model

    Identify if your CT system has the listed Unique Device Identifiers in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Kentucky, Puerto Rico.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Feb 24, 202112. FDA classified it Class II: Mar 17, 202123. Published in FDA’s Enforcement Report: Mar 24, 202134. FDA terminated the recall: Feb 17, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1273-2021 (February 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1273-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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