Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure
Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.
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 failure to issue alarms for vital signs, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Innokas Medical Oy is recalling 20 units of the VC150 Vital Signs Monitor, specifically those equipped with the Masimo SpO2 technique. The affected devices include catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a defect where the monitor does not issue visual and audible alarms if the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode. This failure could prevent healthcare providers from receiving necessary alerts regarding patient vital signs.
The affected units were distributed in the US and Europe. Specific serial numbers for the recalled units are listed in the agency's recall record. Healthcare facilities and consumers should stop using the affected devices and contact Innokas Medical for further instructions.
The recalled product
- Product
- VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
- Manufacturer
- INNOKAS MEDICAL OY
- Hazard
- Affected units
- 20
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)
- SK514470022YA
- SK514470023YA
- SK514470024YA
- SK514470020YA
- SK514470021YA
- SK514100003YA
- SK514470019YA
- SK514470001YA
- SK514470017YA
- SK514470018YA
- SK514450021YA
- SK514450022YA
- SK514450019YA
- SK514470004YA
- SK514470005YA
- SK514390001YA
- SK514150002YA
- SK514150004YA
- SK514150005YA
- SK514300002YA
Distribution
Distribution scope not specified by the agency.
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