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Recall Observatory FDA recall evidence

Device product

AVE 2 Birthing Bed

Z-0991-2019

January 07, 2019

Class II

Product summary

Firm
Linet Spol. S.r.o.
Event
Event 81927
Status
Terminated
Classification
Class II
Quantity
253 devices
Official record key
device-enforcement:Z-0991-2019

Official wording

Reason: LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

Code information: Serial Numbers 4PPB0091 through 4PPB626

Distribution pattern: AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

Field note

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