Class I - Dangerous
Risk of unintended motion while the AIRO system is in transport mode.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Panoramic Rental
Class I - Dangerous
The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Philips Ingenuity Core computed tomography x-ray system
Philips Medical Systems (Cleveland)
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Class I - Dangerous
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
3M Company - Health Care Business
Class I - Dangerous
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Philips Ingenuity CT computed tomography x-ray system
Philips Medical Systems (Cleveland)
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Philips Ingenuity Core 128 computed tomography x-ray system
Philips Medical Systems (Cleveland)
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Mindray DS USA, Inc.
Class I - Dangerous
A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Stryker Medical Division of Stryker
Class I - Dangerous
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Horiba Instruments, Inc
Class I - Dangerous
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
Class I - Dangerous
55 kits were distributed after their expiration date of September 2015.
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Baxter Healthcare
Class I - Dangerous
A leak may allow for microbial contamination of the sterile fluid path.