Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Reported: October 24, 2018 Initiated: September 13, 2018 #Z-0176-2019
Product Description
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Reason for Recall
The service manual was not updated at the time of the release of software version 1.30.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 152
- Distribution
- 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.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 152.
Why was this product recalled? ▼
The service manual was not updated at the time of the release of software version 1.30.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0176-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11