FDA recall Z-1992-2023

Draeger Medical Systems, Inc. · Class II · 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]

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2023-05-16
Report date
2023-06-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Telford, PA, United States

Primary source

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