Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Altaire, Magnetic Resonance Imaging Device.
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Serial numbers: L001 to L191.
Products Sold
Serial numbers: L001 to L191.
Hitachi Medical Systems America Inc is recalling Altaire, Magnetic Resonance Imaging Device. due to 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 pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026