Device recall

Z-1992-2023: Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s)…

FDA device recall · Class II · Draeger Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-1992-2023
Recall event 92353
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
Recalling firm Draeger Medical Systems, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K120642
FEI number 2510954

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)