Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation is recalling the Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) Electronic Gas Blender, catalog number 801188. The device can experience an intermittent failure that causes a blender initialization fault when the system starts up or during a calibration attempt. When this fault occurs, the control sliders on the Central Control Monitor become disabled, meaning the gas system can only be controlled using the local control knobs instead.
Approximately 72 units with specific lot numbers have been distributed nationwide across multiple U.S. states and to Canada, Mexico, and South Korea. The record does not specify a remedy for consumers who have this device.
Written by software from the official notice below. Not reviewed by a lawyer.
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
Reason for recall: An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs. Distribution: Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea. Quantity: 72 Lot/code info: 01338 01339 01340 01341 01342 01349 01350 01351 01352 01353 01354 01355 01356 01357 01358 01360 01361 01362 01363 01365 01366 01367 01369 01370 01371 01372 01373 01374 01375 01376 01377 01378 01379 Lot/Serial 01380 01381 01382 01383 01384 01385 01386 01387 01388 01389 01394 01395 01396 01397 01398 01405 01406 01407 01408 01410 01411 01413 01414 01415 01416 01418 01420 01421 01422 01423 01424 01425 01426 Lot/Serial 01427 01428 01429 01430 01431 01432 01434 01435 1718 2317 4417 9999 UDI 00886799000588
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.