Reported Dec 12, 2012 · Terminated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for…
Natus Medical Incorporated
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Medical Incorporated · 5900 1st Ave S · Seattle, WA · 98108-3248
Is this the product you have?
- The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling
- The device is labeled in parts"***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***"
- Lot codes and dates
324 of 324 codes
100810091011101210141016101710181020102110221023102410251027102810291030103110321034103510361038104410451048105010511052105310541055105610591060106210631064106510661070107110721073107410751076107710791080108110821083108410851086108710881089
- Amount recalled
- 324 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.