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Terminated

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

FDA Recall Z-0176-2019 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2018-09-13
Date Terminated2019-11-18
Product Quantity152

Reason for Recall

The service manual was not updated at the time of the release of software version 1.30.

Firm Action

Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017-08-17

Official Source

View FDA Recall →

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

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