FDA recall Z-1428-2021

Stryker Corporation · Class II · device

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 for recall

Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

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.

Key facts

Status
Terminated
Initiation date
2021-02-26
Report date
2021-04-21
Termination date
2023-12-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2021