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Terminated

e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

FDA Recall Z-0053-04 · Posted 2003-10-24

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2003-09-05
Date Terminated2005-02-24
Product Quantity2,386 units

Reason for Recall

The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.

Firm Action

Siemens sent Important Safety Customer Advisory letters dated 8/27/03 to all e.cam customers on 9/5-12/03. The accounts were informed of the problem with the detector''s radial brake not being applied properly, allowing slow, unintended downward motion of the detector that could result in injury to the patient or operator, and were advised not to leave the patient unattended while on the pallet and not to leave the patient under the detector upon completion of the study. The customers were advised that they would be contacted by their Siemens service provider to schedule a mandatory update to the e.cam to correct the problem. The upgrade will be done free of charge.

Root Cause

Other

Distribution Pattern

Nationwide, United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, Ecuador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, India, Italy, Iran, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Macedonia, Madagascar, Myanmar, Mauritius, Malaysia, Nepal, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, Zimbabwe, South Africa and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952109IP500 NUCLEAR GAMMA CAMERA SYSTEMSiemens Medical Solutions USA, Inc. · 1995-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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