Philips Healthcare Recalls

Hazard: Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used

Hazard: Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

Hazard: Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.

Hazard: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

Hazard: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

Hazard: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use

Hazard: VS2+ screen may lock up and stop monitoring during patient use

Hazard: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

Hazard: Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21

Hazard: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Hazard: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.

Hazard: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator

Hazard: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.

Hazard: The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down

Hazard: Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

Hazard: Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables

Hazard: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount

Hazard: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

Hazard: Essenta DR C-Arm may fall

Hazard: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

Hazard: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG

Hazard: Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

Hazard: HeartStart MRx Unexpected Pads/Paddles ECG Failure

Hazard: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

Hazard: If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut

Hazard: With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side

Hazard: When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie