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Health o Meter Professional Remote Display Digital… recallZ-0294-2012 · Pelstar, Llc · initiated Oct 7, 2011

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Pelstar, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0294-2012
Status
Terminated
Initiated by the company
Oct 7, 2011
Posted by the FDA
Nov 28, 2011
Recalling firm
Pelstar, Llc
Quantity
2,498 units
Product code
FRI
Distribution
Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.

Product description

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 (models, lots, serial numbers)

Model 498KL, UPC Code - 892076002718, Serial numbers 4980000001 through 4980002909

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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