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.
Reported: April 21, 2021 Initiated: February 26, 2021 #Z-1428-2021
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.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 125 units
- Distribution
- 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.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Corporation. Units affected: 125 units.
Why was this product recalled? ▼
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1428-2021.
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