Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model:
FDA device recall Z-1125-2012 · posted 2012-02-29 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Nederlands
- Reason for recall
- There maybe incorrect values in the diffusion/perfusion maps.
- Action taken
- Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customers should contact their local Philips representative at 866-767-2822
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 25 units
- Distribution
- Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
- Date initiated
- 2012-01-27
- Date posted
- 2012-02-29
- Date terminated
- 2021-02-25
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151) | Philips Health Care | 2011-03-22 |
| INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 (K003853) | Philips Medical Systems (Cleveland), Inc. | 2001-02-13 |