CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic p
FDA device recall Z-0572-2016 · posted 2016-01-04 · Terminated
Recall details
- Recalling firm
- Partners In Medicine Llc
- Reason for recall
- Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).
- Action taken
- CNSystems sent an Urgent Medical Device Recall Safety Notice dated December 1, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. CNSystems decided to perform a voluntary recall of the affected devices and to return the devices after repair (free of charge). For questions regarding this recall call 314-324-2470.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DSB
- Quantity affected
- 28 worldwide 2 monitors distributed in the U.S.
- Distribution
- Nationwide Distribution including MI and CA.
- Date initiated
- 2015-12-01
- Date posted
- 2016-01-04
- Date terminated
- 2017-02-17
- Location
- Saint Louis, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TASK FORCE MONITOR 3040 (K014063) | Cnsystems Medizintechnik GmbH | 2002-02-07 |