FDA Device recall Z-2604-2016
CARESCAPE VC150 Vital Signs Monitor
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of CARESCAPE VC150 Vital Signs Monitor by Innokas Medical Oy, citing A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2604-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-27 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Innokas Medical Oy |
| Distribution | AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI |
Product
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Reason
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Identifiers
| code_info | SK514130002YA SK514130016YA SK514150001YA SK514150017YA SK514150020YA SK514150021YA SK514150022YA SK51415…SK514130002YA SK514130016YA SK514150001YA SK514150017YA SK514150020YA SK514150021YA SK514150022YA SK514150032YA SK514450012YA SK514470018YA SK514490005YA SK514490006YA SK514490009YA SK514490010YA SK514490011YA SK514490012YA SK515040001YA SK515050016YA SK515050017YA SK515050018YA SK515050019YA SK515050020YA SK515050021YA SK515050022YA SK515050023YA SK515050024YA SK515050025YA SK515060001YA SK515060002YA SK515060003YA SK515060005YA SK515100057YA SK515100065YA SK515100066YA SK515100068YA SK515110063YA SK515110066YA SK515110073YA SK515110118YA SK515110174YA SK515110183YA SK515110184YA SK515110185YA SK515110186YA SK515110187YA SK515110188YA SK515110189YA SK515110190YA SK515110192YA SK515110193YA SK515110195YA SK515120002YA SK515120003YA SK515120004YA SK515120007YA SK515120008YA SK515120012YA SK515120015YA SK515120017YA SK515120018YA SK515120040YA SK515120042YA SK5151200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2604-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.