FDAFebruary 26, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
What to do
FDA enforcement status: Terminated
Brands named
stryker
UPCs
00858701006049
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
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- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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