| Class 2 Device Recall Puritan Bennett 980 Ventilator System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK
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