Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors
Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic imaging data, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 157 units of IntelliSpace Portal (ISP) software, including models ISP DX/HX/EX, ISP IX, and ISP LX SPECT. The recall affects specific serial numbers distributed worldwide, including the United States and numerous international markets.
The recall is due to software errors in the AutoSPECT Pro application. During SPECT reconstructions using Attenuation Correction and Scatter Correction, the software fails to apply Scatter Correction. Additionally, resolution recovery is not applied correctly in SPECT reconstructions using Astonish. These errors may result in inaccurate diagnostic imaging data.
Healthcare facilities and users of the affected software should contact Philips Medical Systems for further instructions on correcting the software. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 157
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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