| Class 3 Device Recall |  |
Date Initiated by Firm | February 20, 2002 |
Date Posted | July 28, 2004 |
Recall Status1 |
Terminated 3 on December 02, 2004 |
Recall Number | Z-1230-04 |
Recall Event ID |
29385 |
510(K)Number | K001208 K023350 K034040 K981072 |
Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
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Product | Esprit Ventilator |
Code Information |
Too numerous to include. |
Recalling Firm/ Manufacturer |
Respironics California Inc 2271 Cosmos Ct Carlsbad CA 92009-1517
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For Additional Information Contact | Anil Bhalani 760-918-7300 |
Manufacturer Reason for Recall | Flow sensors would exhibit drift. |
FDA Determined Cause 2 | Other |
Action | Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete. |
Quantity in Commerce | 907 |
Distribution | Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam |
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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