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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Affinity Three Birthing Bed.

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 Class 2 Device Recall HillRom Affinity Three Birthing Bed.see related information
Date Initiated by FirmAugust 18, 2006
Date PostedSeptember 14, 2006
Recall Status1 Terminated 3 on July 14, 2009
Recall NumberZ-1503-06
Recall Event ID 36142
510(K)NumberK915779 
Product Classification birthing bed - Product Code KNC
ProductHill-Rom Affinity Three Birthing Bed, Model P3700.
Code Information All units distributed after October 2000 and equipped with the 12VAC accessory outlet option.
FEI Number 1824206
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall		The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.
FDA Determined
Cause 2		Other
ActionCustomers were notified via letter dated 8/18/06 and instructed to either correct the problem themselves with the instructions provided or to contact the firm requesting a visit from the recalling firm to correct their beds.
Quantity in Commerce9,324
DistributionNationwide, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, France, French Polynesia, Germany, Guam, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Sait Kitts and Nevis, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands and Venezuela.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNC
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