Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.
This recall has been terminated (originally issued July 7, 2009).
- Recall Initiated
- April 14, 2009
- Posted
- July 7, 2009
- Terminated
- September 21, 2012
- Recall Number
- Z-1652-2009
- Quantity
- 4 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
Distribution
Nationwide distribution, including Puerto Rico (PR).
Lot / Code Info
The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005
Root Cause
Software design
Action Taken
HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.