Date Initiated by Firm | July 13, 2015 |
Date Posted | August 14, 2015 |
Recall Status1 |
Terminated 3 on March 01, 2017 |
Recall Number | Z-2343-2015 |
Recall Event ID |
71702 |
510(K)Number | K093632 K093633 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. |
Code Information |
Catalog Number(s): 8416400, 8417400 |
Recalling Firm/ Manufacturer |
Draeger Medical, Inc. 3135 Quarry Rd Telford PA 18969-1042
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For Additional Information Contact | Customer Support 215-721-5400 |
Manufacturer Reason for Recall | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge. |
Quantity in Commerce | 2081 |
Distribution | Nationwide Distribution. |
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 510(K)s with Product Code = CBK
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