FDA Device recall Z-0185-2015
GE Healthcare Varicam/VG and VG Hawkeye devices
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of GE Healthcare Varicam/VG and VG Hawkeye devices by Ge Healthcare, citing GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0185-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Reason
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Identifiers
| code_info | 0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 1026…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 1056 512753VG 10481 515263LVG 10 |
|---|
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-0185-2015%22
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