FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Altaire, Magnetic Resonance Imaging Device.
- Recall number
- Z-0846-05
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Altaire, Magnetic Resonance Imaging Device.
- Status
- Terminated
- Initiated
- 2004-11-18
- Posted
- 2005-05-17
- Terminated
- 2008-01-04
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 189 devices
- 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, serial or model codes
- Serial numbers: L001 to L191.
- 510(k) numbers
- ["K002420","K022390"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28