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U.S. Department of Health and Human Services

Class 2 Device Recall Health o Meter Professional

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  Class 2 Device Recall Health o Meter Professional see related information
Date Initiated by Firm October 07, 2011
Date Posted November 28, 2011
Recall Status1 Terminated 3 on November 30, 2017
Recall Number Z-0294-2012
Recall Event ID 60031
Product Classification Scale, stand-on, patient - Product Code FRI
Product Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL

Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).
Code Information Model 498KL, UPC Code - 892076002718, Serial numbers 4980000001 through 4980002909
Recalling Firm/
Manufacturer		 Pelstar, Llc
11800 S Austin Ave
Unit B
Alsip IL 60803-3559
For Additional Information Contact
708-377-0600
Manufacturer Reason
for Recall		 There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst.
FDA Determined
Cause 2		 Device Design
Action Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.
Quantity in Commerce 2,498 units
Distribution Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.
Total Product Life Cycle TPLC 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.
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