FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
- Recall number
- Z-3221-2011
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
- Status
- Terminated
- Initiated
- 2010-12-08
- Posted
- 2011-09-16
- Terminated
- 2013-03-18
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 528 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Units manufactured from January 2005 to September 2007
- 510(k) numbers
- ["K080211"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28