Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil tha
FDA device recall Z-1263-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.
- Action taken
- On 7/30/07, Hitachi sent a Device Correction letter via courier with receipt tracking to all affected customers outlining the risk of overheating of the cable balun assembly and subsequent risk of patient/operator injury. The letter notifies customers that (1) Hitachi will be contacting them in the future to schedule an on-site visit for replacement of the Altaire Shoulder Coil; (2) the replacement will begin in September, 2007 and continue until all affected coils are replaced; and (3) customers that have noticed overheating of the cable balun assembly are urged to notify Hitachi for immediate replacement service.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 273
- Distribution
- Nationwide: U.S. A. to include: AL, AR, AZ, CA, CO, CT, DE, FL, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WY.
- Date initiated
- 2007-07-30
- Date posted
- 2007-09-26
- Date terminated
- 2010-10-05
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |