GE Medical Systems Recalls Mavig Monitor Suspension System Due to Fall Risk
GE Medical Systems is recalling 2,111 Mavig Monitor Suspension Systems because a reported incident involved a suspension arm falling to the floor.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems, LLC is recalling the Mavig Monitor Suspension System, Model GD60, which is contained in various Fluoroscopic imaging systems including the Advantx and INNOVA series. The recall involves 2,111 units distributed worldwide, including 1,078 units in the United States and 1,033 units outside the US.
The recall was initiated after GE Healthcare became aware of a reported incident in which a Mavig suspension arm with a monitor assembly fell to the floor. This defect presents a risk of injury to patients or staff if the equipment falls during use.
Affected units are identified by specific manufacturing lot or serial numbers and system IDs listed in the official recall documentation. Healthcare facilities should contact GE Medical Systems to arrange for inspection and repair of the affected suspension systems.
The recalled product
- 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
- Manufacturer
- GE Medical Systems, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Mfg Lot or Serial #/System ID
- 1003/219326IN41
- 20116/573632CRA
- 30173/229434INNOV
- 9110080/502587LAB4
- 40410078/904276SP
- 50410007/703689LCA2
- 100300002/315448RM2
- 104100042/650369SV5
- 104100047/810342A41
- 104100051/573632CRC1
- 104100057/843674INNOVA
- 106100046/603669ELCV
- 110300023/315448RM1
- 110310015/724656ANG
- 110420162/251435I12
- 120310008/804285CATH2
- 123100037/617789IN1
- 204110049/513861INNOVA
- 204110065/623848LAB1
Distribution
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