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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream Touch Prime

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 Class 2 Device Recall Carestream Touch Primesee related information
Date Initiated by FirmJuly 08, 2016
Date PostedJuly 18, 2016
Recall Status1 Terminated 3 on May 02, 2017
Recall NumberZ-2217-2016
Recall Event ID 74652
510(K)NumberK152467 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductCarestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
Code Information Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043   
Recalling Firm/
Manufacturer		 Carestream Health Inc
150 Verona St
Rochester NY 14608-1733
Manufacturer Reason
for Recall		A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
FDA Determined
Cause 2		Software design
ActionThe firm, Carestream Health Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter dated 7/7/2016 and response form the end users/customers on 7/8/2016 via Certified Mail, Return Receipt Requested. The letter described the product, problem and actions to be taken. The Customers were instructed not use the generic volume measurement tool until Carestream has updated the system software. In the interim, calculate volumes by using the specific volume tool from the desired calculation package. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above. Carestream has created a software update for Touch Ultrasound to resolve this issue and will update your software. Carestreams representative will contact you and schedule a convenient time to upgrade the software. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910 (available on a 24/7 basis). Outside of the US, please call your local Service support number.
Quantity in Commerce7 Units (US: 5 units, OUS: 2 units)
DistributionWorldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
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