Rappel de Device Recall TSX301A: AQUILION One; System, XRay, Tomography, Computed

Recall

59690

Class 2

Z-3196-2011

2011-06-22

2011-09-13

Terminated

United States

2014-08-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103350

Toshiba america medical systems is initiating a field correction on their tsx-301b: aquilion premium; system, x-ray, tomography, computed, tsx-301a: aquilion one; system, x-ray, tomography, computed, tsx-20ia: aqulllon lb; system, x-ray, tomography, computed, and tsx-1o1a: aquilion 16; system, x-ray, tomography, computed due to several software issues that cause the scanners to function incorr.

Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy. 2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy. 3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list. 4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility. Customers were asked to complete and return the attached form and fax it to 877-349-3054. For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.