MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (s

FDA device recall Z-2040-2024 · posted 2024-06-07 · Open, Classified

Recall details

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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.

Action taken

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 find the manufacturing date to determine if it is an affected device. The letter also informs the consignee they will be contacted by a GE HealthCare representative to arrange for the correction.

Root cause

Device Design

Status

Open, Classified

Product code

KPS

Quantity affected

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, Belg

Date initiated

2024-04-15

Date posted

2024-06-07

Location

Tirat Carmel, Israel

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