Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio
FDA device recall Z-2175-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.
- Action taken
- Philips Healthcare notified accounts on 3/16/11 via the Urgent Medical Device Correction Notification. Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. All customers potentially affected by this issue will receive the software correction as part of the field action.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NSX
- Quantity affected
- 387 units
- Distribution
- Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Sau
- Date initiated
- 2011-03-16
- Date posted
- 2011-05-10
- 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 |