Recall Z-3111-2011 ยท DXJ Display, Cathode-Ray Tube, Medical
Philips Healthcare Inc.
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated f
| Date | Aug 31, 2011 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended. |
| Root cause | Software design |
| Action | Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devi |
| Quantity | 454 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF |
| FDA record | Open on fda.gov |