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Lower risk Medical device recall · FDA · Published February 26, 2021

Stryker PINPOINT Video Processor May Flicker or Lose Image - Recall

Stryker recalls PINPOINT Video Processor/Illuminators that may flicker, lose image, or reboot unexpectedly. This medical device is used with SPY-PHI and PINPOINT systems for imaging. Affected units have specific UDI codes.

🇺🇸 FDA recall #Z-1428-2021Medical deviceStryker ›
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Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker is recalling PINPOINT Video Processor/Illuminators that may flicker, lose image, or unexpectedly reboot. This could disrupt medical imaging procedures during surgeries or procedures requiring precise visual guidance. Read more at govinfonow.com/recall/63211-stryker-pinpoint-video-processor-may-flicker-or-lose-image-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/63211-stryker-pinpoint-video-processor-may-flicker-or-lose-image-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1428-2021

Cite this page

“Stryker PINPOINT Video Processor May Flicker or Lose Image - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63211-stryker-pinpoint-video-processor-may-flicker-or-lose-image-recall. Based on FDA recall #Z-1428-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2021%22&limit=1).

Why it’s dangerous

The device may flicker, lose image, or unexpectedly reboot during use with SPY-PHI and PINPOINT systems. This could cause interruptions in medical imaging procedures, potentially affecting surgical accuracy or patient safety.

Who’s affected

Medical professionals using the device with SPY-PHI and PINPOINT imaging systems. Patients undergoing procedures requiring the device are at risk if the device malfunctions during surgery.

How to tell if you have this one

Check for the UDI code (01) 00858701006049 on the device. The product is used with SPY-PHI and PINPOINT systems for medical imaging. The specific model is Stryker REF PC9001.

  • Brand
    Stryker
  • Product
    Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Look for flickering, image loss, or unexpected reboots during use with SPY-PHI or PINPOINT systems.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 17 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Illinois, Massachusetts, Michigan, Mississippi, Nevada, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

1. Firm started the recall: Feb 26, 202112. FDA classified it Class II: Apr 15, 202123. Published in FDA’s Enforcement Report: Apr 21, 202134. FDA terminated the recall: Dec 15, 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-1428-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1428-2021 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