Philips North America Llc recalls dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Read the official notice →- Date
- 2024-12-04
- Country
- United States
- Brand
- Philips
- Product
- dS Breast 16ch 1.5T
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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 recalls
- 2025-02-12
US
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
FDA · DevicePhilips North America LlcUS distribution to Florida, North Carolina, and Oregan. International…Official notice →- 2024-12-25
US
Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to…
- 2024-12-11
US
Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA,…Official notice →- 2024-10-16
US
Philips North America recalls Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC…
US
Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:…
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices.…
FDA · DevicePhilips North America LlcForeign Only: Denmark France Germany Japan United KingdomOfficial notice →- 2024-10-09
US
Philips North America Llc recalls DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips…
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ,…Official notice →
Other drugs & medical recalls in the United States
- 2024-12-04
US
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted…
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA,…Official notice →US
GE Healthcare (China) Co., Ltd. recalls GE Proteus XR/A radiographic system
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
US
INCIPIO DEVICES recalls Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in…
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS,…Official notice →US
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF…
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Official notice →US
Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Control Pump
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS,…Official notice →