Z-1992-2023Class II

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

Name: Z-1992-2023 Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C...
Creator: Draeger Medical Systems, Inc.
Published: 2023-05-16
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2023-05-16 / Open, Classified / root cause: design

FDA source

Draeger Medical Systems, Inc. began a recall of 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... on 2023-05-16. FDA classified it as Class II and gives the reason as "The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1992-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-16
Posted: 2023-06-22
Recalling firm: Draeger Medical Systems, Inc.
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]
Product code: FMT Warmer, Infant Radiant
Reason for recall: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent - Medical Device Correction dated May 2023 was sent to customers. Actions to be taken: Please ensure that all users of the above-mentioned products and other persons within your organization are made aware of this Important Safety Notice. If you have provided the products to third parties, please forward a copy of this information. Users can mitigate this risk by performing the visual check, test procedure and take appropriate actions based on the Attachment provided in this notice. Complete and return the enclosed Customer Acknowledgement and Response Form . We are continuing to evaluate this issue and will advise the affected customers when we have an alternative solution. Visual Check for Correct Mattress Placement: To ensure proper operation of the scale, please check to confirm there is a clearance between the mattress cover and the corner blocks and side panels of the Resuscitaire. 1. Ensure mattress with cover is installed in the Resuscitaire bassinet. 2. Observe edges of mattress for clearance with corner blocks and side panels, see Figure 2. 3. If there is interference, then the scale may not provide accurate weight measurements. It is recommended to use an independent scale for therapeutic decisions and treatment Test Procedure If it is unclear from the visual check if the mattress cover interferes with the corner blocks and/or side panels, impacting scale function, please perform the following test: a. Place a known calibrated weight on the center mattress (with mattress cover installed). A 5kg weight is recommended in the instructions for use. b. Execute weighing procedure and record weight. c. Repeat weighing procedure 5-10 times. d. Compare measurements. i. If measurements are within 5 grams of calibrated 5kg weight, mattress assembly is acceptable. ii. If measurements deviate more than +/- 5 grams from the calibrated 5kg weight, it is recommended to use an alternate weighing scale Contact: We regret any inconvenience this may cause.
Quantity in commerce: 936 units
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.
Product codes and lots: All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-22

Product code FMT

K120642Class IIResuscitaire with AutobreathDraeger Medical Systems, Inc. / cleared 2012-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)