Recall Z-0763-2016— GE Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-18, terminated 2016-09-07. It names 6 FDA 510(k) clearances: K122457, K042053, K022322 and 3 more. Product: Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ. Reason: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-18
- Terminated
- 2016-09-07
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
6 on FDA's record- K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
- K042053 — INNOVA 4100, INNOVA 3100
- K022322 — INNOVA AND INNOVA 2000 S
- 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
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
Reason for recall
GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.