Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full
FDA device recall Z-1988-2012 · posted 2012-07-11 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff
- Action taken
- Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Philips representative or the Customer Care Solutions Center at 1-800-722-9377, option 5, for questions regarding this recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 96
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Rep
- Date initiated
- 2012-05-23
- Date posted
- 2012-07-11
- Date terminated
- 2013-03-28
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |