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Recall Observatory FDA recall evidence

Device product

Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

Z-2018-2014

June 17, 2014

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 68244
Status
Terminated
Classification
Class II
Quantity
1713 units
Official record key
device-enforcement:Z-2018-2014

Official wording

Reason: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

Code information: Catalog Number 801763

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.