TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.

FDA device recall Z-3221-2011 · posted 2011-09-16 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

Reason for recall

There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.

Action taken

Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

528 units

Distribution

Nationwide Distribution.

Date initiated

2010-12-08

Date posted

2011-09-16

Date terminated

2013-03-18

Location

Tustin, CA

Related 510(k) clearances