GE Healthcare recalls Optima NM/CT 640 model 3101RL for loose rotor bearing screws that could cause one of four bearings to release during use. Affected units have specific serial numbers listed in the recall notice.
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
GE Healthcare is recalling Optima NM/CT 640 medical imaging devices with model number 3101RL due to loose rotor bearing screws that may cause a bearing to release. This could lead to equipment malfunction during nuclear medicine procedures.
Loose rotor bearing screws in the detector could cause one of four bearings to release during operation. This might lead to equipment malfunction or failure during nuclear medicine imaging procedures.
Medical facilities using the Optima NM/CT 640 model 3101RL for nuclear medicine imaging are affected. Staff handling these devices are at risk if the bearing release occurs during procedures.
Check for the model number 3101RL on the device. Affected units have specific serial numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021.
Compare your device's serial number to the list: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021.
GE Healthcare found loose rotor bearing screws in one detector that could cause a bearing to release during use, potentially leading to equipment malfunction.
Check your device's serial number against the list provided. If it matches, contact GE Healthcare for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0858-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0858-2021 from GE Healthcare. 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.
