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U.S. Department of Health and Human Services

Class 2 Device Recall E.CAM PHS Field of View Indicator Bars

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 Class 2 Recall
E.CAM PHS Field of View Indicator Bars
see related information
Date Posted June 24, 2009
Recall Status1 Open
Recall Number Z-1505-2009
Recall Event ID 50773
Premarket Notification
510(K) Number
K952109 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product 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).
Code Information part number 43 66 618 (right) and 43 81 088 (left), serial numbers 00001 to 04031
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
For Additional Information Contact Mr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: 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 guide to mitigate the risk for patient injury free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance.
Quantity in Commerce 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, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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