Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
FDA Recall Z-1098-2013 · Posted 2013-04-15
Advertisement
Recalling FirmCarefusion Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-03-06
Date Terminated2014-09-02
Product Quantity9,241 units
Reason for Recall
The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
Firm Action
CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement