GE Medical Systems Israel recalls specific nuclear medicine imaging systems due to risk of detector falling and causing serious injury if mitigation isn't properly implemented.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
GE Medical Systems Israel is recalling certain nuclear medicine imaging systems that could have a detector fall if the safety mechanism isn't correctly set up, potentially causing serious injury. Affected units include specific models with serial numbers listed in the recall notice.
The recall is for systems where the safety mechanism might not work correctly. If this happens, the detector could fall and cause serious injury like a fall or laceration.
Healthcare facilities using the recalled GE Nuclear Medicine 600/800 series systems are most at risk. Patients and staff could be injured if the detector falls during operation.
Check for the specific models: OPTIMA O640 X 3/8 inch NR, DISCOVERY O640 X 3/8 inch, NM OPTIMA O640 X 3/8 inch, or O640 NM Gantry 3/8 inch. Look for serial numbers listed in the recall notice.
Identify your system model and serial numbers to confirm if it's affected by this recall.
Reach out to GE Medical Systems Israel for specific instructions on how to address the issue.
The affected models include OPTIMA O640 X 3/8 inch NR, DISCOVERY O640 X 3/8 inch, NM OPTIMA O640 X 3/8 inch, and O640 NM Gantry 3/8 inch with specific serial numbers listed in the recall notice.
The recall is due to a risk that the safety mechanism might not work correctly, which could cause the detector to fall and lead to serious injury.
No, the recall does not require immediate stoppage. Healthcare facilities should check their system model and contact GE Medical Systems Israel for guidance.
We’ve drafted a message you can send GE Medical Systems Israel to request your refund or repair — edit it as you like.
Subject: Recall Z-1056-2023 — GE Medical Systems Israel GE Medical Systems Israel Hello, I own a GE Medical Systems Israel that is covered by recall Z-1056-2023 from GE Medical Systems Israel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
