Recall Z-1992-2023 ยท FMT Warmer, Infant Radiant
Draeger Medical Systems, Inc.
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]
| Date | Jun 22, 2023 (initiated May 16, 2023) |
| Status | Open, Classified |
| Reason | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. |
| 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120642 | RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc., Nov 2, 2012 |