Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Po
FDA device recall Z-3111-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- 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.
- Action taken
- 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 devices, customers are instructed to follow the instructions for use for the device, which includes the directions to: 1. Always use the medication administration record (MAR) in determining patient care. 2. Always review orders and pending administrations in the administration record after any changes to an order are stored. For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011. If you need any further information or support concerning this issue, please contact your local Philips representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 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, MAL
- Date initiated
- 2011-07-08
- Date posted
- 2011-08-31
- Date terminated
- 2020-08-13
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLIVUE CLINICAL INFORMATION PORTFOLIO (K100272) | Philips Medical Systems | 2010-04-14 |
| HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636) | Hewlett-Packard Co. | 1999-08-31 |