Recall record at a glance
| Official record | Z-2077-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GETINGE US SALES LLC |
| Report date | Jul 31, 2019 |
| Recall initiation date | Jun 5, 2019 |
| Quantity | 7 |
| Location | WAYNE, NJ, United States |
Official product description
PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units
Why the product was recalled
The monitor displays an error message . The error message states "internal error restart or service".
Distribution information
US Nationwide distribution in the states of MD, OK, NY,FL, SC
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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