The Recall Desk
HighFDA (Devices)·Z-1597-2013·Announced 2013-07-03

RF Technologies Recalls Code Alert Advanced 4-Way Care Solution Due to Firmware Error

RF Technologies is recalling 167 Code Alert Advanced 4-Way Care Solution units because a firmware error may delay alarm transmission to the server.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device intended to prevent falls in at-risk patients. The firmware error creates a risk of harm (delayed fall alerts) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

RF Technologies, Inc. has initiated a recall of the Code Alert Advanced 4-Way Care Solution, CA520 System (PN 9600-1600). This medical device is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. A total of 167 units are affected by this recall.

The recall was initiated due to a firmware error that may cause the alarm to not be transmitted to the system server immediately. This delay could potentially impact the timely notification of caregivers regarding patient movement.

The affected units were distributed nationwide in the US, including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI. Consumers and healthcare facilities should contact RF Technologies, Inc. for further instructions on how to resolve the firmware issue or replace the device.

The recalled product

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.
Affected units
167

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all codes

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same hazard · delayed alarm

See all →