GE Healthcare, LLC: VariCam

Is my product affected?

VariCam

• UPC 00000000010
• UPC 00000000017
• UPC 00000000018
• UPC 00000000016
• UPC 00000000030

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare, LLC has recalled 64 VariCam units distributed worldwide due to a potential hazard involving the collimator locking handle. If the handle is not properly placed in the lock position and the warning circuit fails to detect that the collimator is unlocked, a hazardous situation may occur when a patient is in close proximity to the collimator during a clinical scan.

The affected units are identified by specific serial numbers listed in the recall record. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

Details from the source

Reason for recall: A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan. Distribution: Worldwide Quantity: 64 units Lot/code info: Serial Numbers: 0000000010-203 0000000010-191 000003100-1829 00008125-18-18 00000000010-15 00000000010-63 00008125-16-59 000000099-4-04 00000000010-31 00000000010-82 00008125-16-70 00008125-18-09 00008125-18-16 00000000017-64 10280 00000000010-30 000003681-1803 00000000018-24 000003100-1840 000003101-1502 000003100-1744 00000000017-36 00000000016-86 00000000017-31 1065 1998 1999 000008125-1630 1008 00000000017-20 00000000017-22 00000000017-23 1804 00000000030-14 00000000030-15 00000000010-37 00000000010-44 00000000010-55 00000000030-16 00000000018-39 1704 00000ICPO50612 1697 1696 000000163-1758 00000000018-23 00000000016-73 00000000030-04 00000000010-59 00000000018-22 000003100-1760 000003100-1743 0000000010-134 000003100-1719 343 000003100-1763 61061 00000000010-04 00000000030-11 1649 00000000010-67 00000000010-45 00000000017-27 00000000017-15

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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