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Stryker Corporation recalls Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049
Recalled April 21, 2021 · FDA recall Z-1428-2021 · Stryker
Hazard
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. · FDA Class II
Units
125 units
Sold at
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.
Description
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
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.
Manufacturer(s)
Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →