Recall Z-2613-2023 ยท DQK Computer, Diagnostic, Programmable
GE Medical Systems Information Technologies Inc
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
| Date | Sep 19, 2023 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. |
| Root cause | Component design/selection |
| Action | The recalling firm issued letters dated 8/8/2023 on the same day via FedEx. The letters explained the issue and listed actions to be taken by the customer/user. These included: (1) Ensure the facility has stable power. Lower voltage of the supplied power (e.g. 100V) causes more heat buildup and can cause the amplifier to fail; (2) Ensure the room temperature where the device is used is kept at < 30 degrees Celsius/86 degrees Fahrenheit. High temperatures (equal to or greater than 30 degrees Celsius/86 degrees Fahrenheit) can cause the amplifier to fail; (3) Ensure additional devices are |
| Quantity | 81 amplifiers |
| Distribution | Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Softwa Ge Healthcare Information Technologies, Inc., Feb 17, 2022 |