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Terminated

Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.

FDA Recall Z-1198-2010 · Posted 2010-03-23

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHIF
Date Initiated2008-12-29
Date Terminated2011-03-24
Product Quantity884 devices

Reason for Recall

Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and interruption of ongoing surgical procedures.

Firm Action

Recall initiated 12/29/2009. Sales representatives were notified via phone and e-mail, while product advisory notices were sent to consignees via FedEx. Consignees are provided with a response form, and are instructed to run a software correction.

Root Cause

Component design/selection

Distribution Pattern

Product was distributed throughout the US and to Argentina, Brazil, Canada, Chile and Latin America, as well as to 16 government facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K06336745L CORE INSUFFLATOR, MODEL F114W.O.M. World of Medicine AG · 2007-05-23

Official Source

View FDA Recall →

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

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