—#98612

Product

Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link

FDA product code: NSX
510(k) numbers: K100272, K992636
Affected lot / code info: versions D.03, E.0, or E.01 of the software

Why it was recalled

Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2011-03-16
Posted by FDA: 2011-05-10
Terminated: 2020-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.