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U.S. Department of Health and Human Services

Class 2 Device Recall EasyDiagnost

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  Class 2 Device Recall EasyDiagnost see related information
Date Initiated by Firm June 02, 2020
Date Posted July 10, 2020
Recall Status1 Terminated 3 on February 09, 2021
Recall Number Z-2523-2020
Recall Event ID 85810
510(K)Number K031535  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Code Information Serial Numbers  SN16000004  SN17000018  SN17000020  SN17000025  SN17000026  SN18000002  SN18000004  SN18000005 SN16000002 SN16000006 SN16000011 SN16000013 SN16000017 SN16000022 SN16000025 SN16000028 SN16000029 SN16000030 SN16000031 SN16000036 SN16000037 SN16000039 SN16000041 SN16000042 SN16000043 SN16000044 SN16000045 SN16000048 SN16000054 SN16000056 SN17000001 SN17000006 SN17000008 SN17000015 SN17000017 SN17000019 SN17000021 SN17000023 SN17000027 SN17000028 SN17000029 SN17000031 SN17000032 SN17000033 SN17000034 SN17000035 SN17000036 SN17000037 SN17000038 SN18000001  SN18000003  SN18000009 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Kathy LaBrie
678-296-0248
Manufacturer Reason
for Recall		 Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
FDA Determined
Cause 2		 Process control
Action The firm distributed Urgent Field Safety Notice letters to affected customers on 6/2/2020. Customers were informed that the thermos switches may be incorrectly installed which results in a malfunction. If the transformer overheats due to a failure and the thermos switch is not activated, the device may begin to generate smoke. Customers were advised by the firm that they can use the system according to the IFU (Instruction for Use). The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately shut down the system according to IFU or (if present) use emergency off switch in room, remove patient, stop using the system for further examinations and contact customer service. Philips plans to perform an On-Site check of the SPDU thermo contact at affected systems, which will eliminate these issues. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70600103. If you need any further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce 52
Distribution Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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