The Recall Desk
HighFDA (Devices)·Z-1428-2021·Announced 2021-04-21

Stryker PINPOINT Video Processor Recalled for Flickering and Reboots

Stryker is recalling PINPOINT Video Processors/Illuminators that may flicker, lose image, or reboot unexpectedly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (loss of image/reboots) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Corporation is recalling 125 units of the PINPOINT Video Processor/Illuminator (REF PC9001). The recall is due to a potential for the devices to exhibit flickering, loss of image, or unintended reboots.

The affected devices were distributed worldwide, including in the United States and various international locations. The source text does not specify the exact number of reported injuries or illnesses associated with this defect.

Healthcare providers and consumers should stop using the affected devices and contact Stryker Corporation for further instructions on replacement or repair.

The recalled product

Product
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
Affected units
125

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically: