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Class 2 Device Recall HillRom Affinity Three Birthing Bed. |
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Date Initiated by Firm |
August 18, 2006 |
Date Posted |
September 14, 2006 |
Recall Status1 |
Terminated 3 on July 14, 2009 |
Recall Number |
Z-1503-06 |
Recall Event ID |
36142 |
510(K)Number |
K915779
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Product Classification |
birthing bed - Product Code KNC
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Product |
Hill-Rom Affinity Three Birthing Bed, Model P3700. |
Code Information |
All units distributed after October 2000 and equipped with the 12VAC accessory outlet option. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
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For Additional Information Contact |
800-445-3720
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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.
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FDA Determined Cause 2 |
Other |
Action |
Customers 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 Commerce |
9,324 |
Distribution |
Nationwide, 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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KNC and Original Applicant = HILL-ROM, INC.
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