CLASS II Device recall · Reported 16 Jan 2019 · FDA Enforcement Report
VariCam recalled by GE Healthcare
GE Healthcare is recalling VariCam. The recall was initiated on 30 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0704-2019
- FDA event ID
- 81736
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 30 Oct 2017
- FDA classified
- 9 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Oct 2017 | Recall initiated by company | |
| 9 Jan 2019 | Classified by FDA | +436 days |
| 16 Jan 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VariCam
Where it was distributed
Worldwide
Questions about this recall
Is VariCam recalled?
Yes. GE Healthcare recalled VariCam on 30 Oct 2017. The recall is Class II and its status is Completed. Recall number Z-0704-2019.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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