FDA Device recall Z-0704-2019
VariCam
- FDA Device
- Class II
- completed
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of VariCam by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0704-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-10-30 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
VariCam
Reason
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.
Identifiers
| code_info | Serial Numbers: 0000000010-203 0000000010-191 000003100-1829 00008125-18-18 00000000010-15 00000000010-63 000081…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0704-2019%22
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