Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Shutdown Defect
Innokas Medical is recalling 424 CARESCAPE VC150 Vital Signs Monitors because the devices may shut down unintentionally without restarting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may fail to monitor vital signs, posing a risk of harm where injury has not yet been reported.
Plain-English summary
Innokas Medical Oy is recalling the CARESCAPE VC150 Vital Signs Monitor, a device used to monitor vital signs in humans. The recall involves 424 units, including 38 units distributed in the United States and the remainder distributed in Europe. The affected devices are identified by specific catalog numbers (2067980-001 through 2067980-016) and a list of serial numbers provided in the official recall notice.
The recall is being conducted because the monitor may shut down unintentionally without restarting. This defect could result in the loss of vital sign monitoring for patients. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have these devices should stop using them and contact Innokas Medical Oy for instructions on how to return or repair the units. The recall is active in the United States and Europe.
The recalled product
- Product
- CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
- Manufacturer
- Innokas Medical Oy
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 (20)
- Catalog numbers: 2067980-001
- 2067980-002
- 2067980-003
- 2067980-004
- 2067980-005
- 2067980-006
- 2067980-007
- 2067980-008
- 2067980-009
- 2067980-010
- 2067980-011
- 2067980-012
- 2067980-013
- 2067980-014
- 2067980-015
- 2067980-016 Serial Numbers: In USA: SK514470004YA
- SK514470005YA
- SK515050001YA
- SK515050002YA
- SK515050003YA
Distribution
Distributed nationwide across the United States.
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