Altaire, Magnetic Resonance Imaging Device.
FDA device recall Z-0797-05 · posted 2005-05-03 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
- Action taken
- The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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.
- Date initiated
- 2005-04-11
- Date posted
- 2005-05-03
- Date terminated
- 2012-04-12
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HITACHI ALTAIRE (K022390) | Hitachi Medical Systems America, Inc. | 2002-10-11 |
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |