||November 30, 2011
|Recall Event ID
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
||Philips Digital Diagnost Rel 3, a radiographic system, digital
Intended use: Radiographic system, digital
|Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
|For Additional Information Contact
|Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
|PRODUCTION CONTROLS: Process Control
||The firm, Philips Healthcare, sent a "URGENT - Field Safety Notice" letter dated October 25, 2011, to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed: Do not place your hand in the open slot below the Control Handle and ensure that no patient places his/her hands the opening; review the following information with all members of their staff who need to be aware of the contents of this communication, and retain a copy with the equipment instruction for use. Philips has issued a Field Change order instructing Service Engineers to check affected systems and install the cover where it is missing free of charge.
If you need any further information or support concerning this issue call 978-659-4519.
|Quantity in Commerce
||28 (7 US; 2 Canada; 19 OUS)
||Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.
|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)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.