MedComp C3 Wave App Recalled Due to ECG Display Failure
Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device that prevents necessary diagnostic confirmation (ECG) during a procedure is rated as Severe (4), as it poses a significant risk of harm due to the inability to verify tip placement.
Plain-English summary
Medical Components, Inc dba MedComp is recalling 24 units of the C3 Wave App, version 2.0.5. The recall is due to a software malfunction that occurs when the iPad is updated to Apple iOS software version 12.
When the application malfunctions, ECG waves do not appear on the screen in either surface or internal mode. This failure prevents the use of the app to confirm PICC tip placement, requiring the procedure to be completed without using alternate methods for confirmation.
The affected units were distributed to accounts in Arizona, California, Colorado, Florida, Illinois, Louisiana, Massachusetts, Maine, North Carolina, Ohio, Tennessee, Virginia, and West Virginia. Foreign distribution included Canada, Croatia, the Czech Republic, Great Britain, Greece, Italy, the Netherlands, Slovenia, and Sweden.
The recalled product
- Product
- C3 Wave App, v. 2.0.5
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Software
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- v. 2.0.5
- all units
Distribution
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