Device product
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Z-2019-2014
Product summary
- Event
- Event 68244
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1713 units
- Official record key
device-enforcement:Z-2019-2014
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 801764
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
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.