Recall Z-1992-2023— Draeger Medical Systems, Inc.

Name: FDA recall Z-1992-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-16

Class II · Ongoing

Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2023-05-16. It names one FDA 510(k) clearance: K120642. 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]. Reason: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values..

Recalling firm: Draeger Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-16
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K120642 — RESUSCITAIRE WITH AUTOBREATHDraeger Medical Systems, Inc.·cleared 2012-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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]

Reason for recall

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Data sourced from openFDA. This site is unofficial and independent of the FDA.