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July 27, 2000

Respironics Inc. Recalls Infant Apnea Monitors

Marietta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Respironics Inc. is conducting a recall of its Healthdyne SmartMonitor series Infant Apnea Monitors because the  electrical circuit on the display printed circuit board can become damaged.

According to a company spokeswoman, if the electrical circuit is damaged, there's a trace that can short. If this occurs, the two ground points inside the unit may overheat, which could cause some discoloration or potential melting. In rare cases, the monitors could get hot enough to start a fire if something flammable is in direct contact with the monitor (e.g., a cotton blanket sitting on top of the monitor).

Catalog Numbers - 900S, 900S-02, 900S-02-01, 900S-02-04, 900S-02-07, 900SL, 970S, 970S-02, 970S-02-01, 970SE, 970SE-02, 970SE-02-04, 970SE-02-07.
Note: serial numbers relate to year and month. A-L=January-December; first numerical character defines year, 5-9=1995-1999. This recall involves all type 3A and 3B SmartMonitors Infant Apnea Monitors
manufactured between 12/1/95 to 1/15/2000.

Respironics Inc., Marietta, Georgia.

Manufacturer, by distributing field correction kits to all customers on March 29, 2000. Firm-initiated field correction ongoing.  Although this recall began on the date above - this is the first public notice issued by the FDA.

Nationwide and international.

28,000 were distributed.

FDA recall #Z-861-0.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafeMail subscribers July 27, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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