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.
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
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.
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.
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.
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.
Look for flickering, image loss, or unexpected reboots during use with SPY-PHI or PINPOINT systems.
The device may flicker, lose image, or reboot unexpectedly, which could disrupt medical imaging procedures. It is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so contact Stryker directly for guidance on next steps.
Check for the UDI code (01) 00858701006049 on the device. The product is used with SPY-PHI and PINPOINT systems for medical imaging.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1428-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1428-2021 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.