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Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UD...

FDA Device Recall #Z-1428-2021 — Class II — February 26, 2021

Recall Summary

Recall Number Z-1428-2021
Classification Class II — Moderate risk
Date Initiated February 26, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Corporation
Location San Jose, CA
Product Type Devices
Quantity 125 units

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.

Distribution Pattern

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.

Lot / Code Information

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 PI20372914 PI20022701 PI19342372 PI20072784 PI20463054 PI20082798 PI20112863 PI20312881 PI20372915 PI20082788 PI19372413 PI20072787 PI20463058 PI20082799 PI20112864 PI20312882 PI20372916 PI20463062 PI19432511 PI20362904 PI20463036 PI20082801 PI20112865 PI20312883 PI20372917 PI14350291 PI20052727 PI20362905 PI20082804 PI20112866 PI20322885 PI20372918 PI15150533 PI20052728 PI20362906 PI20082805 PI20112867 PI20322886 PI20372919 PI15240575 PI20052732 PI20362907

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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