RecallRadar

FDA Device recall Z-1428-2021

Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: us…

On 2021-04-21 the FDA classified a Class II recall of Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: us… by Stryker, citing their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1428-2021
ClassificationClass II
Statusterminated
Initiated2021-02-26
Published2021-04-21
Last updated2026-09-13 11:56 UTC
CompanyStryker
DistributionUS

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.

Identifiers

code_info
PI20362910 PI20082806 PI20112868 PI20322887 PI20372920 PI16180922 PI20052735 PI20362908 PI20362911 PI20092807…PI20362910 PI20082806 PI20112868 PI20322887 PI20372920 PI16180922 PI20052735 PI20362908 PI20362911 PI20092807 PI20112869 PI20322888 PI20372921 PI17381211 PI20052740 PI20362909 PI20362913 PI20102835 PI20112870 PI20322889 PI20372922 PI17381214 PI20062759 PI20463033 PI20362912 PI20102836 PI20112871 PI20322890 PI20372923 PI18041369 PI20062766 PI20463038 PI20022723 PI20102839 PI20112872 PI20322891 PI20052734 PI18041410 PI20062768 PI20463041 PI20022724 PI20102846 PI20112873 PI20362892 PI20052736 PI18181490 PI20062771 PI20463042 PI20022725 PI20102851 PI20112874 PI20362893 PI20062747 PI18241579 PI20062772 PI20463046 PI20022726 PI20112852 PI20112875 PI20362894 PI20062754 PI19182075 PI20072773 PI20463049 PI20062749 PI20112860 PI20112876 PI20362895 PI20082802 PI19182080 PI20072780 PI20463051 PI20082795 PI20112861 PI20282879 PI20362896 PI20092808 PI19242192 PI20072781 PI20463052 PI20082797 PI20112862 PI20282880 PI20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.