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Recall Observatory FDA recall evidence

Device product

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Z-2158-2021

July 08, 2021

Class II

Product summary

Firm
Sunrise Medical (US) LLC
Event
Event 88257
Status
Terminated
Classification
Class II
Quantity
4,741 device
Official record key
device-enforcement:Z-2158-2021

Official wording

Reason: The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Code information: Model Numbers: EIZ14; Serial Numbers: ZV-001340 through ZV-006153

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of United Kingdom, Germany, France, Canada, Italy, Netherlands, Poland, Czech Republic, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.