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U.S. Department of Health and Human Services

Class 2 Device Recall MobileDiagnost wDR

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 Class 2 Recall
MobileDiagnost wDR
see related information
Date Posted August 21, 2013
Recall Status1 Open
Recall Number Z-1964-2013
Recall Event ID 65839
Premarket Notification
510(K) Number
K111725 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Code Information System Code - 712001
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Phillips Healthcare sent an Important Notification letter dated July 10, 2013 to all affected customer. The notification informed customers that Philips will implement an update to the Instruction for Use (IFU). Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in Commerce 240 systems US -- 1 system within Puerto Rico
Distribution US Nationwide Distribution including Puerto Rico
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SEDECAL SA
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