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U.S. Department of Health and Human Services

Class 2 Device Recall PVT681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems

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  Class 2 Device Recall PVT681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems see related information
Date Initiated by Firm January 05, 2010
Date Posted July 13, 2010
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-1997-2010
Recall Event ID 55544
510(K)Number K092179  K072918  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code ITX
Product PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.
Code Information SERIAL NO. LAST 4 MFG DATE 1 A7582075 2075 Aug. 2007 2 A7582079 2079 Aug. 2007 3 A7622164 2164 Feb. 2007 4 A7582081 2081 Aug. 2007 5 A7582068 2068 Aug. 2007 6 A8512207 2207 Jan. 2008 7 A8582246 2246 Aug. 2008 8 A8572233 2233 Jul. 2008 9 A7582069 2069 Aug. 2007 10 A8512206 2206 Jan. 2008 11 A8572230 2230 Jul. 2008 12 A8512202 2202 Jan. 2008 13 A7582067 2067 Aug. 2007 14 A8512194 2194 Jan. 2008 15 A7582065 2065 Aug. 2007  16 A7622167 2167 Feb. 2007 17 A7622168 2168 Feb. 2007 18 A8512191 2191 Jan. 2008 19 A8512211 2211 Jan. 2008 20 A8572245 2245 Jul. 2008 21 A8582251 2251 Aug. 2008 22 A8582252 2252 Aug. 2008 23 A8512208 2208 Jan. 2008 24 A8512210 2210 Jan. 2008  25 A8572235 2235 Jul. 2008 26 A8572234 2234 Jul. 2008 27 A7582085 2085 Aug. 2007 28 A7582078 2078 Aug. 2007 29 A7582071 2071 Aug. 2007 30 A7582086 2086 Aug. 2007 31 A7582087 2087 Aug. 2007  32 A7582088 2088 Aug. 2007 33 A8512203 2203 Jan. 2008 34 A8572236 2236 Jul. 2008 35 A8572237 2237 Jul. 2008 36 A9512321 2321 Jan. 2009 37 A8572231 2231 Jul. 2008 38 A8582249 2249 Aug. 2008 39 A8582248 2248 Aug. 2008 40 A9562441 2441 Jun. 2009 41 A9562442 2442 Jun. 2009 42 A9562443 2443 Jun. 2009 43 A8512209 2209 Jan. 2008 44 A8512195 2195 Jan. 2008 45 A8582247 2247 Aug. 2008 46 A7582066 2066 Aug. 2007 47 A7582072 2072 Aug. 2007 48 A7582073 2073 Aug. 2007 49 A7582076 2076 Aug. 2007  50 A8512205 2205 Jan. 2008 51 A7582070 2070 Aug. 2007 52 A7582080 2080 Aug. 2007 53 A7582082 2082 Aug. 2007 54 A8512204 2204 Jan. 2008 55 A8512201 2201 Jan. 2008 56 A7582083 2083Aug. 2007
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG (
FDA Determined
Cause 2		 Other
Action Toshiba America Medical Systems (TAMS) will issue notification to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. matter. Questions regarding this letter are directed to the firm at (800) 421-1968 or to your local Toshiba representative.
Quantity in Commerce 27
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
510(K)s with Product Code = ITX and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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