Recall Z-0313-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital
| Date | Nov 30, 2011 (initiated Nov 1, 2011) |
| Status | Terminated |
| Reason | Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit |
| Root cause | Process control |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |