04

Jan

2006

Inc, Class II Toshiba American Med Sys

0

Company: Toshiba American Med Sys, Inc.
Date of Enforcement Report:1/4/2006
Class:II

PRODUCT
a) Digital Radiography System
Model DFP8000D, Recall # Z-0324-06;
b) Digital Radiography System,
Model DFP-8000D/FPD,
Recall # Z-0325-06

REASON
To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.

CODE
Serial Numbers: A3622068 A4512074
A3582042 A3542012 A4512073 A3552017
A4552098 A3622065 A3622066 A4542090
A3592048 B4602125 B4612134 B5512155
B4582116 W1B0542168 A3572018 A4562102
A35B2041 B4612132 A3542011 A3582037
A3622069 B4622149 B4602129 A3542006
B4612133 A3572032 A3522002 B4622146
A3542008 A3602050 A4512076 A4522079
A4522081 B4622150 B5522162 A3592046
A3532005 A3612057 A4572109 A3517002
B4622148 A4562099 A3612061 A4562101
B4612137 A3602055 A4542092 B5512154
A4542088 A3572030 A3582035 A3522004
A3562022 A3582036 B4622151 A3582013
A3582013 A45721 07 B4612141 A3517003
A4522080 A3522001 W180542173;
b) Serial Numbers: B5522165 B4592121
B4602124 B4602126 W1B0542172
W1B0542174 B4582115 B4622147 B4572111
B5522161 B5512160 A4562105 B4582113

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys, Inc., Tustin, CA, by letter on November 10, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
85 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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