PHILIPS MEDICAL SYSTEMS Recalls

Hazard: When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.

Hazard: MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Hazard: MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

Hazard: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication

Hazard: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.

Hazard: A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si

Hazard: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

Hazard: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

Hazard: VCG battery ignited in a VCG unit when recharging.

Hazard: Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

Hazard: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

Hazard: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Hazard: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Hazard: Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.

Hazard: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

Hazard: In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

Hazard: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

Hazard: It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.

Hazard: Mold on gel filled Gel-E and Squishon products

Hazard: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.

Hazard: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.

Hazard: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

Hazard: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

Hazard: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Hazard: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.

Hazard: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Hazard: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Hazard: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Hazard: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Hazard: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.