July 27, 2000Respironics Inc. Recalls Infant
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,
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