Recall Z-1428-2021— Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Corporation, initiated 2021-02-26, terminated 2023-12-15. It names one FDA 510(k) clearance: K150956. 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.. Reason: Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-26
- Terminated
- 2023-12-15
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Data sourced from openFDA. This site is unofficial and independent of the FDA.