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Recall Observatory FDA recall evidence

Device product

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]

Z-1992-2023

May 16, 2023

Class II

Product summary

Firm
Draeger Medical Systems, Inc.
Event
Event 92353
Status
Ongoing
Classification
Class II
Quantity
936 units
Official record key
device-enforcement:Z-1992-2023

Official wording

Reason: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Code information: All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, VT, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.