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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare System Xray Tomography Computed

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  Class 2 Device Recall Philips Healthcare System Xray Tomography Computed see related information
Date Initiated by Firm March 15, 2016
Create Date November 22, 2016
Recall Status1 Terminated 3 on September 09, 2020
Recall Number Z-0376-2017
Recall Event ID 75551
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Healthcare System X-ray Tomography Computed :
Code Information Ingenuity CT, Ingenuity Core, Ingenuity Core 128.
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		 It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.
Quantity in Commerce 1363
Distribution USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
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.
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