Magnetic Resonance Imaging Device
This recall has been terminated (originally issued May 31, 2006).
- Recall Initiated
- February 21, 2006
- Posted
- May 31, 2006
- Terminated
- February 16, 2012
- Recall Number
- Z-0910-06
- Quantity
- 1129
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
Distribution
Nationwide
Lot / Code Info
L001-L225 - Altaire C001-C693* - AIRIS II C701-C790 - AIRIS II Upgrades H001-H091 - AIRIS Elite H701-H748* - AIRIS Elite Upgrades *The firm informed CIN-DO in their status reports for May, 2006 and again in August, 2007, that duplication was found in the number of system units originally reported to CIN-DO in early 2006. Ten (10) of the AIRIS II System units had been previously upgraded to AIRIS Elite units [System Unit Numbers: C012, C014, C032, C063, C111, C138, C263, C347, and C495] and are these numbers are reflected in the total # of AIRIS Elite System Unit Numbers listed above* **By the same token, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746, H747 & H748] were reportedly installed well after the corrective action was underway (7/28/06 to 11/24/2006) and were not-subject to corrective action. As a result, the total # of affected system units/customers has been revised to reflect the number reported by the firm [1129] beginning with their May, 2006 status report and continuing through to their final communication to CIN-DO dated 8/21/2007. - clp
Root Cause
Other
Action Taken
The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.