Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital
FDA device recall Z-0313-2012 · posted 2011-11-30 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 28 (7 US; 2 Canada; 19 OUS)
- 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.
- Date initiated
- 2011-11-01
- Date posted
- 2011-11-30
- Date terminated
- 2017-01-17
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |