Z-2204-2011

CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography...

Name: Z-2204-2011 CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography...
Creator: Toshiba American Medical Systems Inc
Published: 2010-04-09
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-04-09 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed on 2010-04-09. The reason FDA records is "The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2204-2011
Status: Terminated
Initiated: 2010-04-09
Posted: 2011-05-19
Terminated: 2012-08-17
Recalling firm: Canon Medical Systems USA, Inc.
Product: CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems (TAMS) forwarded an Urgent: Medical Device Correction letter, dated 4/6/10, with attached Customer Reply Form, via US Postal Service to all customers who purchased the CHVH-001A/1B variable helical pitch (vHP) software for TSX-I0IA: Aquilion 64. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that a Toshiba service representative would contact them to schedule an appointment in order to install a corrective measure that will prevent the occurrence of the problem. Toshiba would like customers to set a scan range different from that for the previous scan for the second and subsequent vHP scans, if multiple vHP scans with the same scan conditions are performed in Auto Mode. Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to [email protected]. Customers with any questions can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Representative at (800) 521-1968.
Quantity in commerce: 35
Distribution: Nationwide Distribution -- MN, OH, MO, MI, NY, KS, MD, TX, NJ, IL, ID, TN, AZ, PA, HI, GA, MT, WA, FL, NC, WI, ME, & CA.
Product codes and lots: SERIAL NUMBERS: 2089, 2114, 2302, 3204, 2037, 2014, 2040, 2898, 2054, 2042, 2067, 2202, 2241, 2100, 2038, 2101, 2102, 2244, 2097, 2931, 2900, 3085, 2412, 2595, 2106, 2041, 2108, 2113, 2130, 2135, 2147, 2158, 2063, 2157, 2161, and 2243.

Product code JAK

K080211Class IIModel Tsx-101A/h/i Aquilion 32/64 Sp CT SystemToshiba America Medical Systems, In.C / cleared 2008-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)