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Terminated

Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

FDA Recall Z-0589-2010 · Posted 2010-01-05

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2009-11-17
Date Terminated2012-06-04
Product Quantity29364 (8438 of those in US)

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.

Firm Action

Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884520SERVO VENTILATOR 900ESiemens-Elema Ventilation Systems · 1989-01-17K871254ACCULEVEL CARBAMAZEPINE TESTSyva Co. · 1987-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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