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Terminated

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.

FDA Recall Z-1597-2013 · Posted 2013-06-26

Recalling FirmRF Technologies, Inc.
Recall StatusTerminated
Product CodeKMI
Date Initiated2013-05-17
Date Terminated2013-12-03
Product Quantity167

Reason for Recall

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.

Firm Action

Consignees were sent on 5/17/2013 a "Medical Device Recall" letter dated 3 May 2013. The letter described the problem and the product involved in the recall. The letter advised consignees to discontinue use of the device and return to RF Technologies.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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