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Terminated

ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

FDA Recall Z-0819-05 · Posted 2005-05-11

Recalling FirmCTI PET Systems Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2005-04-05
Date Terminated2009-09-11
Product Quantity80 units

Reason for Recall

Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.

Firm Action

Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, the Netherlands, Ireland & Denmark

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003241ECAT PET SCANNERCti Pet Systems, Inc. · 2000-12-13K002584ECAT ACCEL PET SCANNERCti Pet Systems, Inc. · 2000-11-16K962797ECAT EXACT & ECAT EXACT HR+Cti Pet Systems, Inc. · 1996-10-15

Official Source

View FDA Recall →

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

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