Resuscitaire Radiant Warmer Class II 2095 units

Resuscitaire Radiant Warmer, Infant Radiant Warmer:

a) Resuscitaire Radiant Warmer, Model RW81;

b) Resuscitaire Radiant Warmer, Model RW82;

c) Resuscitaire Radiant Warmer, Model RW82VHA;

d) Resuscitaire Radiant Warmer, Model WMRW82;

e) Resuscitaire Radiant Warmer, Model WBR 81;

f) Resuscitaire Radiant Warmer, Model WBR82.

Recall #Z-292/297-9.

REASON

The device fails to control heater power due to a software error.

CODE

Units with software versions prior to 1.061.

MANUFACTURER

Hill-Rom Air-Shields, formerly Air-Shields, Inc., a division of Vickers Medical, Hatboro, Pennsylvania.

RECALLED BY

Manufacturer, by letter dated June 12, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

2,095 units were distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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