FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Altaire, Magnetic Resonance Imaging Device.
- Recall number
- Z-0797-05
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Altaire, Magnetic Resonance Imaging Device.
- Status
- Terminated
- Initiated
- 2005-04-11
- Posted
- 2005-05-03
- Terminated
- 2012-04-12
- Reason
- The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
- Root cause
- Other
- Action
- The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.
- Quantity
- 212 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 L212
- 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