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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream

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  Class 2 Device Recall Carestream see related information
Date Initiated by Firm March 19, 2019
Create Date April 23, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-1207-2019
Recall Event ID 82491
510(K)Number K173478  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product OnSight 3D Extremity System- X-Ray, Tomography Computed System
Catalog Numbers:
1743566 (w/ Attached Console)
1743574 (w/ Remote Console)

The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Code Information US Serial Numbers: 58008585 58007506 58000020 58008493 58000015 58007502 58007504 58008494 58007503 58008018 58007505 58008500 58008011 58008014  OUS: 10012 20005 20012 20016 20007 20017 10018 10004 10007 20004 20008 10023 10009 20019 20013 10002 10003 10014 10010 20006 20022 20003 20010  
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
For Additional Information Contact SAME
585-781-1997
Manufacturer Reason
for Recall		 When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
FDA Determined
Cause 2		 Software design
Action Carestream issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 15, 2019 on March 19, 2019 via USPS Certified Mail Return Receipt Requested, describing problem, risk to health and corrective action. Carestreams representative will contact to schedule a convenient date and time within the next 6 months to install the software update. In the meantime, please use extreme caution to ensure proper reassignment of both parent and companion volumes whenever reassignment to a different patient is required. Also complete and return the Consignee Notification Acknowledgement form by e-mail to: postmarketra@carestream.com. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact the Carestream Customer Care Center as instructed above. Questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call the local Carestream Service support number.
Quantity in Commerce 37 units
Distribution Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.
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 = JAK and Original Applicant = Carestream Health, Inc.
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