# FDA recall Z-0929-2024

> **Philips North America** · Class I · device recall initiated 2023-12-15.

## Product

BrightView, gamma camera system;    Model Nos.:    6-digit format 882480;  12-digit format 453560279781  453560279791  453560279811  453560279801;  4x4 digit format  2170-3000A  2170-3001A  2170-3002A  2170-3003A

## Reason for recall

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

## Distribution

Domestic distribution nationwide. International distribution worldwide.

## Key facts

- **Recall number:** Z-0929-2024
- **Recalling firm:** Philips North America
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-15
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2024

## Citation

> AI Analytics. FDA recall Z-0929-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0929-2024. Source: US FDA. Licensed CC0.

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