Recall Z-1212-2013— 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: K103238. Product: Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, 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
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, 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.