FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
- Recall number
- Z-1678-2014
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
- Status
- Terminated
- Initiated
- 2014-03-11
- Posted
- 2014-06-02
- Terminated
- 2015-08-04
- Reason
- During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.
- Root cause
- Software design
- Action
- On 03/10/2014 the firm sent Urgent Medical Device Correction Letters to their customers.
- Quantity
- 157 units
- Distribution
- Worldwide distribution, including US nationwide, Argentina, Australia, Austria, Canada, Cayman Islands, Chile, Denmark, Finland, France, Germany, India, Iraq, Israel, Italy, Latvia, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Turkey and United Kingdom.
- Lot, serial or model codes
- ISP DX/HX/EX; Model number 881001, Serial numbers 35033, 85298, 80861, 81017, 81021, 81191, 82085, 82124, 82144, 82148, 82242, 85029, 85030, 85033, 85164, 85166, 85183, 85247, 85302, 85324, 85337, 85353, 85357, 85359, 85397, 85401, 85402, 87004, 87014, 87158, 87176, 87177, 87182, 87200, 92003, 95043, 95044, 95045, 95046, 95047, 95048, 95049, 95050, 95051, 95052, 95054, 850001, 870030, 870071, 870073, 870076, 920007, 920008, 950006, 950023, 950031, 950039, 950041, 950045, 950052, 950071, 950084, 950085, 950087, 950106, 950119, 950120, 950121, 950129, 950137, 950143 and 950146. ISP IX; Model number 881030, Serial numbers 40024, 40021, 40031, 40036, 40044, 40061, 40082, 40088, 40096, 40145, 40146, 40148, 40150, 40155, 40158, 40160, 40169 and 600003. ISP LX SPECT; Model number 881035, Serial numbers 40001, 40003, 40033, 40084, 40087, 40093, 40133, 40134 and 40141.
- 510(k) numbers
- ["K012009","K033326","K060937","K110151"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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