Medication dispensing servers recalled over delayed updates from enterprise systems
CareFusion 303 is recalling 2,079 BD Pyxis ES Enterprise Server systems over a software issue that may result in equipment not receiving timely updates of patient or medication information.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: dispensing equipment may not receive timely patient or medication updates, and no injuries are reported.
Plain-English summary
The BD Pyxis ES Enterprise Server is being recalled by CareFusion 303, Inc., across the catalog numbers listed in the enforcement record including 1115-00, 137672-02 and 137671-02.
The reason given in the enforcement record is a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
The record lists 2,079 systems, with UDI-DI codes for hardware and software recorded in the enforcement record. Distribution was worldwide, including nationwide across the United States. The FDA has classified the action as Class II.
Dispensing equipment that does not receive timely patient or medication updates may act on outdated information. The enforcement record reports no injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 2,079
Distribution
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