Recalls / —

—#77136

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).

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K952109

Affected lot / code info

part number 43 66 618 (right) and 43 81 088 (left), serial numbers 00001 to 04031

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc.

Address

2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2008-12-18

Posted by FDA

2009-06-24

Terminated

2011-05-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #77136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.