Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monit
FDA device recall Z-1098-2013 · posted 2013-04-15 · Terminated
Recall details
- Recalling firm
- Carefusion Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 9,241 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-15
- Date terminated
- 2014-09-02
- 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 |