FDA-Device2023-06-28Class II

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]

Draeger Medical Systems, Inc.
Hazard

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

Sold states
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.
Affected count
936 units
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
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]

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2023

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