Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1
Summary
The FDA issued a Class II for Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): R by Draeger Medical Systems, Inc.. Reason: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values..
Details
Source
Device Recall
External ID
Z-1992-2023
Action Date
2023-06-28
Status
Ongoing
Category
device
Product Description
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]
Lot/Code Info: All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001
Quantity Affected: 936 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-16
Company
Telford, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 246 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger Medical Systems, Inc. have FDA actions?
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1992-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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