Recall Z-1211-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-03-28, terminated 2013-10-25. It names one FDA 510(k) clearance: K080048. Product: MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.. Reason: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2013-10-25
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Reason for recall
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Data sourced from openFDA. This site is unofficial and independent of the FDA.