# FDA recall Z-2040-2024

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class II · device recall initiated 2024-04-15.

## Product

MyoSPECT System, Model H3912AA and H3912B,  and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).

## Reason for recall

There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, NC, ND, NV, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Belgium, Brazil, Canada, Czech Republic, Finland, France, India, Israel, Italy, Japan, Malaysia, Malta, Poland, Singapore, Spain, Taiwan, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-2040-2024
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-15
- **Report date:** 2024-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tirat Carmel, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2024

## Citation

> AI Analytics. FDA recall Z-2040-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2040-2024. Source: US FDA. Licensed CC0.

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