Reported Aug 31, 2016 · Terminated
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Innokas Medical Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INNOKAS MEDICAL OY · TARJUSOJANTIE 12 · KEMPELE · N/A
Is this the product you have?
- CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
- Lot codes and dates
1,715 of 1,715 codes
SK514130002YASK514130016YASK514150001YASK514150017YASK514150020YASK514150021YASK514150022YASK514150032YASK514450012YASK514470018YASK514490005YASK514490006YASK514490009YASK514490010YASK514490011YASK514490012YASK515040001YASK515050016YASK515050017YASK515050018YASK515050019YASK515050020YASK515050021YASK515050022YASK515050023YASK515050024YASK515050025YASK515060001YASK515060002YASK515060003YASK515060005YASK515100057YASK515100065YASK515100066YASK515100068YASK515110063YASK515110066YASK515110073YASK515110118YASK515110174YASK515110183YASK515110184YASK515110185YASK515110186YASK515110187YASK515110188YASK515110189YASK515110190YASK515110192YASK515110193YASK515110195YASK515120002YASK515120003YASK515120004YASK515120007YASK515120008YASK515120012YASK515120015YASK515120017YASK515120018YA
- Amount recalled
- 1715 units
Where it was sold
Why it was recalled
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
This product could cause temporary or reversible health problems — stop using it.
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