Cardiac SPECT System Recalled for Defective Service Handle Fastening
GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device with no reported injuries or hospitalizations. The handles could loosen and allow a heavy cover to drop, creating potential for injury to service personnel. Per the rubric, risk-of-harm products where injury has not yet been reported score as 3 (High).
Plain-English summary
GE Medical Systems Israel, Functional Imaging is recalling MyoSPECT System models H3912AA and H3912B, and MyoSPECT ES System models H3912AB and H3912BD, dedicated cardiac single-photon emission computerized tomography (SPECT) imaging systems.
The devices are being recalled due to a defect in the service handles for internal lead covers. The handles could loosen or release, potentially allowing the heavy cover to drop and cause injury to service personnel who perform maintenance on these systems.
A total of 133 devices are affected by this recall. In the United States, affected devices have been distributed to Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington. Internationally, the devices have been distributed to Argentina, Belgium, Brazil, Canada, Czech Republic, Finland, France, India, Israel, Italy, Japan, Malaysia, Malta, Poland, Singapore, Spain, Taiwan, Turkey, and the United Kingdom.
If you own or operate one of these systems, contact GE Medical Systems for identification and corrective action instructions. Affected devices were manufactured on or before February 13, 2024 for MyoSPECT models, and on or before February 15, 2024 for MyoSPECT ES models.
The recalled product
- Product
- MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Affected units
- 133
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- MyoSPECT manufactured on or before 2024-02-13: Model H3912AA
- GTIN 00195278421586 - Serial numbers NGCC80094
- NGCB80033
- NGCB80044
- NGCB80045
- NGCA80017
- NGCB80039
- NGCA80006
- NGCA80011
- NGCA80003
- NGCA80012
- NGCB80052
- NGCB80060
- NGCC80074
- NGCC80081
- NGCB80038
- NGCD80107
- NGCB80070
- NGCC80093
- NGCD80106
Distribution
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