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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan Bennett 980 Ventilator System

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  Class 2 Device Recall Puritan Bennett 980 Ventilator System see related information
Date Initiated by Firm January 15, 2016
Date Posted March 17, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall Number Z-1181-2016
Recall Event ID 73096
510(K)Number K131252  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx).

Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
Code Information all versions of software.
Recalling Firm/
Manufacturer		 Covidien LP (formerly Nellcor Puritan Bennett Inc.)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact Technical Support
800-255-6774
Manufacturer Reason
for Recall		 Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified via an Urgent Medical Device Safety Notification, dated February 8, 2016, on 1/14/16. The letter identified the affected device and the issues involved. Consignees are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Medtronic is investigating the root cause of these conditions and will provide a service update to resolve the issues as soon as corrections can be implemented. Customers are to complete the attached form and return it per the instructions to confirm receipt and understanding of the information. Questions or issues should be directed to the Technical Support Department at 800-255-6774.
Quantity in Commerce 1,864 units
Distribution Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = COVIDIEN
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