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Terminated

Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.

FDA Recall Z-0571-05 · Posted 2005-03-08

Recalling FirmMaquet Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-01-03
Date Terminated2005-09-08
Product Quantity7920 units

Reason for Recall

Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

Firm Action

Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.

Root Cause

Other

Distribution Pattern

The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970839SERVO VENTILATOR 300ASiemens Elema AB · 1997-10-14K902859SERVO VENTILATOR 300Siemens Life Support Systems · 1991-04-26

Official Source

View FDA Recall →

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

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