Draeger Resuscitaire Warmer Scale May Display Inaccurate Weight Values
Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall affecting critical neonatal care equipment. Although no injuries or illnesses have been reported, this defect affects accurate weight measurement—essential for safe clinical decision-making and medication dosing in newborn care—meeting the criteria for risk-of-harm products without reported injury.
Plain-English summary
Draeger Medical Systems, Inc. is recalling Softbed Resuscitaire and Birthing Room Warmer models RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1, and WBR82-1C equipped with optional scales.
The recalled units may display inaccurate weight values. Accurate weight measurement is critical in neonatal care for medication dosing, nutritional assessment, and growth monitoring. Inaccurate readings could lead to incorrect clinical decisions for newborns.
Approximately 936 units have been distributed nationwide across 38 states, the District of Columbia, and Puerto Rico. The affected units were shipped between January 20, 2020 and March 1, 2023.
Affected healthcare facilities should verify weight readings through alternative measurement methods and contact Draeger Medical Systems, Inc. for instructions on remediation or device replacement.
The recalled product
- 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]
- Manufacturer
- Draeger Medical Systems, Inc.
- Hazard
- inaccurate-weight-display
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All units shipped from January 20
- 2020 through March 1
- 2023
Distribution
Distributed nationwide across the United States.
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