—#105032

Product

Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K982795
Affected lot / code info: S/N: SN11000009 SN11000012 SN11000014 SN11000015 SN11000016 SN11000017 SN11000025 SN11000029 SN11000013 SN11000020 SN11000022 SN11000005 SN11000008 SN11000010 SN11000003 SN11000019 SN11000034 SN11000004 SN11000018 SN11000023 SN11000024 SN11000006 SN11000007 SN11000011 SN11000026 SN11000027 SN11000028 SN11000002

Why it was recalled

Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

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.

Timeline

Recall initiated: 2011-11-01
Posted by FDA: 2011-11-30
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.