Philips Ultrasound, Inc. recalls 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300…
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer…
Read the official notice →- Date
- 2024-05-15
- Country
- United States
- Brand
- Philips Ultrasound
- Product
- 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of CA, CO, CT,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Ultrasound recalls
- 2025-12-10
USPhilips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
FDA · DevicePhilips Ultrasound, LLCWorldwide US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-09-03
- US
Philips Ultrasound, Inc recalls TRANSDUCER L12-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-07-09
- US
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
FDA · DevicePhilips Ultrasound, IncDomestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium,…Official notice → - 2023-11-15
- US
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
FDA · DevicePhilips Ultrasound, Inc.US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS:…Official notice → - 2023-09-13
- US
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact…
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric…
FDA · DevicePhilips Ultrasound, Inc.Worldwide - US Nationwide distribution including in the states of FL, MN, AZ,…Official notice → - 2021-10-27
- US
Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary…
FDA · DevicePhilips Ultrasound IncUS: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA.…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-15
- US
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- US
Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used…
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
- US
SPINEART SA recalls PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55…
Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but…
FDA · DeviceSPINEART SAU.S. Nationwide distribution in the states of CA, and KY. Not provided due to…Official notice → - US
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x…
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the…
- US
Vyaire Medical, Inc. recalls Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX.…
Potential of the nozzle separating during patient use.
- US
Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result…
FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice →