Z-1597-2013 Class II Terminated
FDA device recall Z-1597-2013 was initiated by RF Technologies, Inc. on May 17, 2013 and is designated Class II. 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 syst… The recall status is terminated (terminated December 3, 2013). Affected quantity: 167.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- May 17, 2013
- Termination Date
- December 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
Code Information
all codes