# FDA recall Z-2341-2025

> **GE Medical Systems, LLC** · Class II · device recall initiated 2025-07-02.

## Product

GE HealthCare OEC 9800.

## Reason for recall

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2341-2025
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-02
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2025

## Citation

> AI Analytics. FDA recall Z-2341-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2341-2025. Source: US FDA. Licensed CC0.

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