FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA Inc: Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
- Recall number
- Z-0273-2008
- Recalling firm
- Siemens Medical Solutions USA Inc
- Product
- Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
- Status
- Terminated
- Initiated
- 2007-07-23
- Posted
- 2007-11-29
- Terminated
- 2009-09-11
- Reason
- Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.
- Root cause
- Software design
- Action
- Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.
- Quantity
- 117 units
- Distribution
- Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
- Lot, serial or model codes
- Serial Numbers: 070-001012, 070-001021, 070-001022, 070-001024, 080-001014, 1001, 1005, 1009, 101007, 1011, 1026, 3600063-00-0001002, 3600063-00-0001004, 3600063-00-0001005, 3600063-00-0001007, 3600063-00-0001008, 3600070-00-0001001, 3600070-00-0001003, 3600070-00-0001006, 3600070-00-0001007, 3600070-00-0001008, 3600070-00-0001013, 3600070-00-0001015, 3600070-00-0001016, 3600070-00-0001017, 3600070-00-0001018, 3600070-00-0001019, 3600070-00-0001023, 3600070-01-0001001, 3600070-01-001002, 3600070-01-001004, 3600070-01-001006, 3600070-01-001008, 3600070-01-001011, 3600070-01-001017, 3600070-01-001020, 3600070-01-001027, 3600070-01-001037, 3600070-01-001043, 3600070-01-001063, 3600076-00-0001001, 3600076-00-0001002, 3600076-00-0001003, 3600080-00-0001002, 3600080-00-0001003, 3600080-00-0001004, 3600080-00-0001006, 3600080-00-0001007, 3600080-00-0001008, 3600080-00-0001009, 3600080-00-0001010, 3600080-00-0001011, 3600080-00-0001012, 3600080-00-0001013, 3600080-00-0001016, 3600086-00-0001002, 3600086-00-0001003, 3600086-00-0001004, 3600089-00-0001002, 3600089-00-0001003, 3600089-00-0001004, 3600089-00-0001005, 3600089-00-0001006, 3600089-00-0001007, 3600089-00-0001008, 3600089-00-0001010, 3600089-00-0001011, 3600089-00-0001012, 3600089-00-0001013, 3600089-00-0001014, 3600089-00-0001017, 3600089-00-0001018, 3600089-00-0001019, 3600089-00-0001021, 3600089-00-0001022, 3600098-00-0101002, 3600098-00-0101003, 3600098-00-0101004, 3600098-00-0101005, 3600098-00-0101006, 3600098-00-0101008, 3600098-00-0101009, 3600098-00-0101010, 3600098-00-0101012, 3600098-00-0101013, 3600098-00-0101015, 3600098-00-0101016, 3600098-00-0101017, 3600098-00-0101018, 3600098-00-0101019, 3600098-00-0101020, 3600098-00-0101021, 3600098-00-0101022, 3600098-00-0101023, 3600098-00-0101024, 3600098-00-0101025, 3600098-00-0101026, 3600098-00-0101027, 3600098-00-0101030, 3600098-00-0201028, 3600098-00-0201029, 3600098-00-0201031, 3600098-00-0201032, 3600098-00-0201033, 3600098-00-0201034, 3600098-00-0201035, 3600098-00-0201036, 3600098-00-0201037, 3600098-00-0201038, 3600098-00-0201039, 3600098-00-0301040, 3600098-00-0401044, 3800098-00-0201034, 401045, 9501006, 9601002, 9801029
- 510(k) numbers
- ["K002584","K003541","K940478","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