Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit,
FDA device recall Z-0983-2014 · posted 2014-02-14 · Terminated
Recall details
- Recalling firm
- Invivo Corporation
- Reason for recall
- Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio.
- Action taken
- Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated December 4, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to refer to the "Action to be Taken by Customer/User section on the attached pages. A Philips representative will contact the customer regarding their affected devices. All affected devices will have a firmware update installed to correct the problem free of charge. If you need any further information or support concerning this problem, please contact your local Philips representative: 877-468-4861 option 1, then option 2. Philips apologizes for any inconveniences caused by this problem.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 299
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom.
- Date initiated
- 2013-12-04
- Date posted
- 2014-02-14
- Date terminated
- 2016-09-12
- Location
- Orlando, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESSION INFORMATION PORTAL (K121424) | Invivo Corporation | 2012-06-13 |