Recall Z-0021-2014— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-08-16, terminated 2014-05-30. It names 6 FDA 510(k) clearances: K023178, K022322, K993037 and 3 more. 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-16
- Terminated
- 2014-05-30
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
6 on FDA's record- K023178 — INNOVA 4100
- K022322 — INNOVA AND INNOVA 2000 S
- K993037 — LCV+ VERSION 2
- K974367 — ADVANTX LCN, ADVANTX LCLP
- K960575 — ADVANTX LCV+
- K945375 — ADVANTX LCA
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.