CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report

Code Alert Advanced 4-Way Care Solution, CA520 System, PN recalled

RF Technologies is recalling Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, distributed nationwide in the US. The recall was initiated on 17 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes

Quantity recalled167

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1597-2013
FDA event ID: 65361
Recalling firm: RF Technologies, Brookfield, WI
Classification: Class II
Status: Terminated
Recall initiated: 17 May 2013
FDA classified: 26 Jun 2013
Reported: 3 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 May 2013	Recall initiated by company
26 Jun 2013	Classified by FDA	+40 days
3 Jul 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alaska Arizona California Georgia Iowa Kentucky Montana North Dakota Nebraska New Jersey Wisconsin

Questions about this recall

Is Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600 recalled?

Yes. RF Technologies recalled Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600 on 17 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1597-2013.

Why was it recalled?

Which lots are affected?

all codes

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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