Altaire, Magnetic Resonance Imaging Device.
- Recall Initiated
- November 18, 2004
- Posted
- May 17, 2005
- Terminated
- January 4, 2008
- Recall Number
- Z-0846-05
- Quantity
- 189 devices
- Firm Location
- Twinsburg, OH
Reason for Recall
The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
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 L191.
Root Cause
Other
Action Taken
The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
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