Change Healthcare Enterprise Viewer
CHANGE HEALTHCARE CANADA COMPANY
🏥 Medical Devices Class I - Dangerous
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
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95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
🏥 Medical Devices Class I - Dangerous
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
🏥 Medical Devices Class I - Dangerous
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
🏥 Medical Devices Class I - Dangerous
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Boston Scientific
🏥 Medical Devices Class I - Dangerous
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
🏥 Medical Devices Class I - Dangerous
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
🏥 Medical Devices Class I - Dangerous
The incorrect dental pins were packaged and subsequently distributed.
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
🏥 Medical Devices Class I - Dangerous
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
🏥 Medical Devices Class I - Dangerous
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
🏥 Medical Devices Class I - Dangerous
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor
🏥 Medical Devices Class I - Dangerous
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
Medela AG Medical Technology
🏥 Medical Devices Class I - Dangerous
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.