Recall Z-1263-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts.
| Date | Sep 26, 2007 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 immedia |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002420 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc., Oct 17, 2000 |