Reported Nov 6, 2019 · Terminated
C3 Wave App, v. 2.0.5
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438-2936
Is this the product you have?
C3 Wave Appv. 2.0.5
- Lot codes and dates
- v. 2.0.5; all units
- Amount recalled
- 24
Where it was sold
Why it was recalled
When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
This product could cause temporary or reversible health problems — stop using it.
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