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U.S. Department of Health and Human Services

Class 2 Device Recall PC Board PC1772 Spare PArt

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  Class 2 Device Recall PC Board PC1772 Spare PArt see related information
Date Initiated by Firm September 19, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on July 22, 2015
Recall Number Z-0354-2012
Recall Event ID 60338
510(K)Number K041223  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Maquet PC Board PC1772 Spare Part
Device Part number 64 67 620

Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.
Code Information 510 k 041223 Device Listing No. B052264 
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Whitney Torning
973-709-7660
Manufacturer Reason
for Recall		 Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).
FDA Determined
Cause 2		 Vendor change control
Action The firm, Maquet Getinge Group, sent an " PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment. If you have any questions, call technical support at our toll free number at 1-888-627-8383.
Quantity in Commerce 10 units
Distribution Nationwide distribution.
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 = MAQUET CRITICAL CARE AB
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