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ATMOS Air-Charged Pressure Sensor
MEDKONSULT medical technology s.r.o. · Model PS11-02U05 · UDI-DI 08594211570565
10
510(k) clearances
119
Adverse events (1 deaths)
3
Recalls
56
Facilities
Description
Air-Charged Pressure Sensor intended for measurement of urodynamic pressures transmitted by approved types of measuring, air-filled catheters in a set of specified urodynamic measurement systems, urethral 0.5m for Harmony
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-17 | LABORIE MEDICAL TECHNOLOGIES, CORP | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to |
| 2018-07-03 | ConvaTec, Inc | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. |
| 2006-10-04 | Laborie Medical Technologies | Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M |
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