Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
All Recalls
95,018 total recalls in our database
BD Pyxis Mini Main REF: 349 Medication cabinet
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
Kico Knee Innovation Company
🏥 Medical Devices Class I - Dangerous
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
🏥 Medical Devices Class I - Dangerous
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
Pediatric care bed; Product Designation: KayserBett IDA;
KAYSERBETTEN GMBH & CO. KG
🏥 Medical Devices Class I - Dangerous
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
Daavlin Distributing Company
🏥 Medical Devices Class I - Dangerous
Some of the Calibration/Output Certificates had the outputs reversed.
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
GE Medical Systems China Co.
🏥 Medical Devices Class I - Dangerous
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
🏥 Medical Devices Class I - Dangerous
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Due to incorrect shelf-life expiration date.
🏥 Medical Devices Class I - Dangerous
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Due to customer complaint regarding incorrect display box labeling.
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
BD Pyxis MedStation ES REF: 323 Medication cabinet
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
🏥 Medical Devices Class I - Dangerous
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.