IntelliSpace Portal recall
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical…
Why was IntelliSpace Portal recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Recall date
- June 11, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)