# FDA recall Z-0062-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-03-19.

## Product

AIR Technology Anterior Array, Catalogue Numbers:  (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.

## Reason for recall

The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.

## Distribution

Worldwide Distribution - US Nationwide  in the states of AZ, CA, MS, NY, WI, DE,  and countries of France, Germany, Japan, Netherlands, Spain, Sweden,

## Key facts

- **Recall number:** Z-0062-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-19
- **Report date:** 2019-10-16
- **Termination date:** 2020-03-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2020

## Citation

> AI Analytics. FDA recall Z-0062-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0062-2020. Source: US FDA. Licensed CC0.

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