TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system suppo

FDA device recall Z-1665-2011 · posted 2011-03-16 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

Reason for recall

Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.

Action taken

The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to raffairs@tams.com. If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

43 units

Distribution

Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.

Date initiated

2010-07-22

Date posted

2011-03-16

Date terminated

2011-04-05

Location

Tustin, CA

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