FDA Medical Device Recalls (openFDA)
CTI PET Systems Inc: 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
- Recall number
- Z-0819-05
- Recalling firm
- CTI PET Systems Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2005-04-05
- Posted
- 2005-05-11
- Terminated
- 2009-09-11
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 80 units
- Distribution
- Nationwide, Canada, the Netherlands, Ireland & Denmark
- Lot, serial or model codes
- Model Number: 3600079-00 Serial numbers: 0001013, 0001014 Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054 Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063 Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082, Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110 Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018 Model Number: 3600085-00 Serial numbers: 0001001, 0001002 Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062 Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060 Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108 Model Number: 3600099-00 Serial numbers: 0301024 Model Number: 3600088-00 Serial numbers: 001058 Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061
- 510(k) numbers
- ["K002584","K003241","K962797"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28