Recall Z-1843-2012 ยท MXM Cap, Cooling (Infants)
Natus Medical Incorporated
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with H
| Date | Jun 20, 2012 (initiated May 21, 2012) |
| Status | Terminated |
| Reason | Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. |
| Root cause | Component design/selection |
| Action | Natus Medical Incorporated sent a URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTIONS Olympic Cool-Cap System letter dated May 21, 2012, to all affected customers. Fed-Ex to all U.S. customers, specifically to Biomedical department, NICU, with affected devices. The letter identified the product the problem and the action needed to be taken by the customer. In addition, Natus also sent the Urgent Field Safety Notice-Olympic Cool-Cap System (DOC-007459) dated May 2012 to all US customers and International Distribution Partners who were affected by both Frozen Screen and Power Supply field correc |
| Quantity | 181 units |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.