The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatmen

FDA device recall Z-0447-2013 · posted 2012-11-30 · Terminated

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.

Action taken

The firm, Natus Medical Incorporated, sent its customers an "URGENT: MEDICAL DEVICE" letter dated May 16, 2012 with an attached Field Safety Notice. The letter describes the product, problem and actions taken. Customers can call Natus Technical Service at 888-496-2887 for any questions about this recall.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MXM

Quantity affected

324 units

Distribution

Worldwide distribution: USA (nationwide) including states of: AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, a

Date initiated

2012-05-09

Date posted

2012-11-30

Date terminated

2015-01-27

Location

Seattle, WA