Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a disp
FDA device recall Z-1096-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Invivo Corporation
- Reason for recall
- Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use.
- Action taken
- Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 3, 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 software update installed in order to correct the problem free of charge. Contact your local Philips representative for further information and support.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 271
- Distribution
- Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.
- Date initiated
- 2013-10-03
- Date posted
- 2014-02-26
- 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 |