Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital
FDA Recall Z-0313-2012 · Posted 2011-11-30
Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2011-11-01
Date Terminated2017-01-17
Product Quantity28 (7 US; 2 Canada; 19 OUS)
Reason for Recall
Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.