Lcv+ Version 2
510(k) K993037
Lcv+ Version 2 is a Class II device made by GE Medical Systems, Inc., cleared under FDA 510(k) K993037 on 14 Feb 2000, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993037 | Date14 Feb 2000 | StatusActive |
Official records
- FDA 510(k) database K993037
Recalls
-
- Terminated Z-0021-2014
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
-
- Terminated Z-2238-2010
A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager and the patient. This will result in loss of the x-ray image if the recovery process is not performed. The error message to use the Emergency Back-Out Button for
-
- Terminated Z-0620-2010
Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient
-
- Terminated Z-0393-2011
- Terminated Z-0392-2011
GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. GE Healthcare has obse
-
- Terminated Z-2435-2008
The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
Timeline
- Cleared FDA 510(k) K993037
- Recall initiated FDA recalls Z-2435-2008
- Recall initiated FDA recalls Z-0393-2011
- Recall initiated FDA recalls Z-0392-2011
- Recall initiated FDA recalls Z-0620-2010
- Recall initiated FDA recalls Z-2238-2010
- Recall initiated FDA recalls Z-0021-2014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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