FDA Device recall Z-1279-2015
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1279-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Reason
GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date
Identifiers
| code_info | Mfg Lot or Serial # System ID 0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262…Mfg Lot or Serial # System ID 0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 10269 208529VG 1078 209334LNVG1 10340 209526milvg 10541 212562VG 1081 225763MVG 000003100-1829 228818MILLVG 00008125-18-18 248338MLO02 10237 248828VG 10326 248937VG 1538 256235OPNM1 10171 262785vg 1039 2894872VG2 1080 2894872VG3 10316 301896VG 10177 304256VG 00000000010-15 304487VG 10156 305612VG 10197 309662SJVG 10539 310231VGH1 10395 312864VG 1058 313299VG 00000000010-63 334794MILVG 1372 361575VG 000000099-4-04 402449SJVG 10189 404605PVGH 1107 407277fvg2 1132 407896FVG1 10211 407933KVG 10438 408947VG 10199 409291HVG 10460 410955VG1 10359 410955VH 10406 412359VG 00000000010-31 413781VG1 00000000010-82 413781VG2 10547 414219VG 10375 414328VG 10534 414384vg 10182 414447VG 3874990 414544VG 5007 414777MIL 10139 414777VG2 10555 414961vg 1141 443643VG 10347 480981NM1 10354 508997VG 10338 510486VG1 105 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1279-2015%22
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