Recall Z-1597-2013 ยท KMI Monitor, Bed Patient
RF Technologies, Inc.
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.
| Date | Jun 26, 2013 (initiated May 17, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 167 |
| Distribution | Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.