CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report
IntelliSpace Portal recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling IntelliSpace Portal, distributed nationwide in the US. The recall was initiated on 23 May 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1987-2012
- FDA event ID
- 62005
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2012
- FDA classified
- 11 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 23 May 2012 | Recall initiated by company | |
| 11 Jul 2012 | Classified by FDA | +49 days |
| 18 Jul 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
Where it was distributed
Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
Questions about this recall
Why was it recalled?
The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
Which lots are affected?
Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995.
Where was it sold?
Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems (Cleveland)
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |