Class 2 Device Recall SV 300/300A

• Date Initiated by Firm: November 17, 2009
• Date Posted: January 05, 2010
• Recall Status: Terminated on June 04, 2012
• Recall Number: Z-0588-2010
• Recall Event ID: 53843
• 510(K)Number: K902859 K970839
• Product Classification: ventilator - Product Code CBK
• Product: Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
• Code Information: Serial numbers 00410-24999. Ventilators in the specific range that are marked with one of the following labels are already equipped with the new type ot pressure transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745 SV900 66 82 747
• Recalling Firm/ Manufacturer: MAQUET Inc.; 45 Barbour Pond Drive; Wayne NJ 07470
• For Additional Information Contact: James Molloy; 973-709-7227
• Manufacturer Reason for Recall: Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
• FDA Determined Cause: Device Design
• Action: Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
• Quantity in Commerce: 20837 (7847 of those in US)
• Distribution: Worldwide 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; 510(K)s with Product Code = CBK