Recall Z-1505-2009 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
| Date | Jun 24, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up FOV indicator bars. |
| Root cause | Device Design |
| Action | Siemens sent Urgent Field Correction Recall letters dated 12/18/08 to all users of the E.cam Systems. The accounts were informed of the potential risk to patients when they attempt to pull themselves up from the patient handling system (PHS) without any assistance and grabbing the field of view (FOV) indicator bar (aka flip-up armrests). The customers were advised to always assist the patient when getting on/off of the PHS. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective upgrade to the PHS with a modified FOV guid |
| Quantity | 1,107 units |
| Distribution | Worldwide distribution: USA, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Me |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952109 | IP500 NUCLEAR GAMMA CAMERA SYSTEM Siemens Medical Solutions USA, Inc., Aug 23, 1995 |