Z-0704-2019Class II

VariCam

Name: Z-0704-2019 VariCam
Creator: GE Healthcare, LLC
Published: 2017-10-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-10-30 / Completed

FDA source

GE Healthcare, LLC began a recall of VariCam on 2017-10-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0704-2019
Classification: Class II
Status: Completed
Initiated: 2017-10-30
Posted: 2019-01-09
Recalling firm: GE Healthcare
Product: VariCam
Product code: KPS System, Tomography, Computed, Emission
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.
FDA root cause: Other
Action: The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products.
Quantity in commerce: 64 units
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0704-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2019	Class II	Completed	Voluntary: Firm initiated	2019-01-16	2019-01-09
Z-0704-2019	Class II	Completed	Voluntary: Firm initiated	2019-01-16	2019-01-09

Product code KPS

K953801Class IIVaricamElscint, Inc. / cleared 1995-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)