Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital
This recall has been terminated (originally issued November 30, 2011).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- November 1, 2011
- Posted
- November 30, 2011
- Terminated
- January 17, 2017
- Recall Number
- Z-0313-2012
- Quantity
- 28 (7 US; 2 Canada; 19 OUS)
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
Distribution
Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.
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
Root Cause
Process control
Action Taken
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.