Recall Z-1654-2009 ยท DXJ Display, Cathode-Ray Tube, Medical
Philips Healthcare Inc.
Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management.
| Date | Jul 7, 2009 (initiated May 5, 2009) |
| Status | Terminated |
| Reason | Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies. |
| Root cause | Software design |
| Action | Philips notified customers by Urgent Medical Device Correction Notification letter on May 6, 2009. The 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 corrections. The corrections will be in the form of software upgrades and will be performed by Philips service personnel. On May 27, 20 |
| Quantity | 105 units |
| Distribution | Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A Hewlett-Packard Co., Aug 31, 1999 |