Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert care
FDA device recall Z-1597-2013 · posted 2013-06-26 · Terminated
Recall details
- Recalling firm
- RF Technologies, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KMI
- Quantity affected
- 167
- Distribution
- Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
- Date initiated
- 2013-05-17
- Date posted
- 2013-06-26
- Date terminated
- 2013-12-03
- Location
- Brookfield, WI
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