Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usa
FDA device recall Z-0534-2014 · posted 2013-12-20 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
- Action taken
- CareFusion sent an Urgent Medical Device Recall Notification letter dated December 5, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to contact CareFusion Customer Advocacy at (888) 812-3266, if they experienced a SYSTEM ERROR on the Alaris PC unit. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to complete and return the enclosed Customer Response Card to expedite the corrective action process. Customers with questions were instructed to contact CareFusion Support Center at 888-562-6018, or for Technical Support call 888-812-3229.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 4824 total units (4242 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
- Date initiated
- 2013-12-05
- Date posted
- 2013-12-20
- Date terminated
- 2016-06-02
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |
| MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (K041241) | Alaris Medical Systems, Inc. | 2004-07-06 |