FDA Device recall Z-0010-2015
GE Healthcare Precision 500D, Classical R&F System
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of GE Healthcare Precision 500D, Classical R&F System by Ge Healthcare, citing GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspensio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0010-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-05 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Reason
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 0000014947…Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0 210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64 00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9 423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500 00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9 904202RF 00000149495MO4 208557RM1 00000149496MO2 515226RF 00000149498MO8 847535RF1 00000149499MO6 704210RX5 00000149500MO1 515226RF2 00000149501MO9 970244AMPRF2 00000149502MO7 215750PRECIS1 00000149503MO5 504447P500 00000149505MO0 602344RM7 00000149506MO8 609584RM1 00000149507MO6 603433PRF3 00000149508MO4 828766R2 00000149509MO2 210297SEBRF3 00000149510MO0 651232RF4 00000149511MO8 502868RF1 00000149512MO6 314525SARM2 000001495 |
|---|
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-0010-2015%22
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