Altaire, Magnetic Resonance Imaging Device.
FDA Recall Z-0846-05 · Posted 2005-05-17
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Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-11-18
Date Terminated2008-01-04
Product Quantity189 devices
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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