FDA Device recall Z-0021-2014
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose di…
- FDA Device
- Class II
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class II recall of GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose di… by Ge Healthcare, citing GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 310….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0021-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-16 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Reason
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 0000003402…Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9 083016598280384 00000245186BU2 RU1488RX20 00000249068BU8 34090VAS01 00000023887YY3 205599LCV 00000055095YY4 207283LC1 00000030139YY0 210428VCATH2 00000023954YY1 212604LC2 00000048123YY4 212604LCA2 00000048175YY4 214376VADV1 00000034312YY9 215576LC2 00000063851YY0 215662LCLP1 00000034351YY7 215955LCEP 00000034379448 216343LCA 00000026282YY4 216363LC 00000023914YY5 216384LCA 00000034355YY8 |
|---|
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-0021-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.