Altaire, Magnetic Resonance Imaging Device.
This recall has been terminated (originally issued May 3, 2005).
- Recall Initiated
- April 11, 2005
- Posted
- May 3, 2005
- Terminated
- April 12, 2012
- Recall Number
- Z-0797-05
- Quantity
- 212 devices
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
Distribution
Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Lot / Code Info
Serial numbers: L001 to L212
Root Cause
Other
Action Taken
The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.
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