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Recall Observatory FDA recall evidence

Device product

Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

Z-2599-2021

August 11, 2021

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 88548
Status
Ongoing
Classification
Class II
Quantity
122 units
Official record key
device-enforcement:Z-2599-2021

Official wording

Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

Code information: N/A

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.