Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philip
FDA device recall Z-2270-2014 · posted 2014-08-19 · Terminated
Recall details
- Recalling firm
- Invivo Corporation
- Reason for recall
- The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
- Action taken
- The firm, Philips Healthcare, sent an "URGENT - Field Safety Notice" dated June 30, 2014 to its customers. The notice describes the product, problem and actions to be taken. The notice also provides the customers with instructions for use while waiting for the update to the IP5. A Philips representative will contact you regarding your affected device. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 573 devices.
- Distribution
- Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC,
- Date initiated
- 2014-06-30
- Date posted
- 2014-08-19
- Date terminated
- 2016-12-14
- Location
- Orlando, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESSION INFORMATION PORTAL (K121424) | Invivo Corporation | 2012-06-13 |