Recall Z-2040-2024 ยท KPS System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
| Date | Jun 7, 2024 (initiated Apr 15, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | The recalling firm issued letters on and dated 4/15/2024 via FedEx informing the consignee of the safety issue and actions to be taken by the customer/user. The actions state the consignee can continue to use the system but until GE HealthCare implements the correction for this potential issue on the affected device and before conducting any servicing activities that involve movement of the covers, GE HealthCare Service should be contacted for guidance. An acknowledgement form was enclosed for completion and return. The letter contained an embedded photograph of the device showing where to |
| Quantity | 133 devices |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212004 | MyoSPECT, MyoSpect ES GE Healthcare, Aug 27, 2021 |