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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 Carestreamsee related information
Date Initiated by FirmJanuary 30, 2023
Date PostedMarch 02, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1206-2023
Recall Event ID 91698
510(K)NumberK201373 
Product Classification System, x-ray, stationary - Product Code KPR
ProductDRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
Code Information UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144 OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2 SP0900 S0625
FEI Number 1317307
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
For Additional Information ContactSAME
585-627-8886
Manufacturer Reason
for Recall		After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
FDA Determined
Cause 2		Software design
ActionCarestream issued Urgent Medical Device Correction Letter to Director of Radiology, Chief Radiology Administrator and DRX-Compass/DR-FIT X-ray System Administrators (US) consignees on 1/30/23. Letter states reason for recall, health risk and action to take: Do not use the Z-Axis Motorized button on the Tube Head Display at this time. Use the Brake Release buttons (Items 5 or 8) to manually move the OTC in the Z-Axis. " Press any E-stop button to stop unexpected movement immediately. " A Service Representative will install a Firmware correction. Action to be taken: A Carestream Service Engineer or Carestream Health Authorized Representative will contact your site and setup a service call to inspect your device and install a new firmware version. For your convenience, a Notification Acknowledgement form has been provided with this letter. Please read and complete the information within 5 working days. Remit the completed form by e-mail to: postmarketra@carestream.com. Questions or concerns, please 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 your local Carestream S vice support number
Quantity in Commerce72 units
DistributionWorldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPR
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