FDA Device recall Z-1022-2015
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only)
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only) by Innokas Medical Oy, citing if the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1022-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Innokas Medical Oy |
| Distribution | n/a |
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.
Reason
If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Identifiers
| code_info | SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA,…SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1022-2015%22
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