Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital t
FDA device recall Z-0112-2015 · posted 2014-10-28 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Reason for recall
- A software issue may lead to ventilator inoperative situations.
- Action taken
- The firm sent Urgent: Field Correction Action letters, dated October 3, 2014, to consignees. The letter identified the affected product and the reason for the recall. Customers were provided actions to be taken, as well as, important safety reminders. The letter informed customers that they may continue to use their ventilators pending the software correction as long as two gas sources are connected to the ventilator at all times. Customers are to complete the attached acknowledgement and receipt form and fax it to Covidien at the number provided. For further assistance, customers are to contact the Technical Support Department at 1-800-255-6774.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 324 units
- Distribution
- Worldwide Distribution -- USA, including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, WI; and, the countries of Canada, Mexico, Saudi Arabia, South Africa, and United
- Date initiated
- 2014-10-01
- Date posted
- 2014-10-28
- Date terminated
- 2016-05-02
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM (K131252) | Covidien | 2014-02-24 |