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Recall Observatory FDA recall evidence

Device product

Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

Z-1597-2013

May 17, 2013

Class II

Product summary

Firm
RF Technologies, Inc.
Event
Event 65361
Status
Terminated
Classification
Class II
Quantity
167
Official record key
device-enforcement:Z-1597-2013

Official wording

Reason: RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately.

Code information: all codes

Distribution pattern: Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware error