Device Recall Tabs Professional Monitor, Model 25025 의 리콜

Recall

61796

Class 2

Z-2490-2012

2012-05-04

2012-09-28

Terminated

United States

2013-09-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109110

The monitor may fail to sound an alarm.

Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.