25

Aug

2004

Daavlin Distributing Co Class III

0

Company: Daavlin Distributing Co.
Date of Enforcement Report: 8/25/04
Class: II

PRODUCT
a) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #PASNBSM-2424. Recall # Z-1233-04;
b) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #ASNBSM-2424. Recall # Z-1234-04;
c) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #LNBH-0048. Recall # Z-1235-04;
d) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #SNBSM-0048. Recall # Z-1236-04;
e) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #ANBSM-0048. Recall # Z-1237-04.

REASON
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.

CODE
All Touch Control System units manufactured between 6/5/03 and 4/30/04.

RECALLING FIRM/MANUFACTURER
Daavlin Distributing Co., Bryan, OH, by service representative visit beginning on September 1, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
68 units.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

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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