Altaire, Magnetic Resonance Imaging Device.
FDA Recall Z-0797-05 · Posted 2005-05-03
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-04-11
Date Terminated2012-04-12
Product Quantity212 devices
Reason for Recall
The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
Firm Action
The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.
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.