# FDA recall Z-1428-2021

> **Stryker Corporation** · Class II · device recall initiated 2021-02-26.

## 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

- **Recall number:** Z-1428-2021
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1428-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1428-2021. Source: US FDA. Licensed CC0.

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