Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may…
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- Philips
- Product
- Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
- Classification
- Class II
- Units
- Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-09-07
US
Philips North America Llc recalls DigitalDiagnost C50 1.1
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in…
- 2022-05-18
US
Philips North America Llc recalls Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of…
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure…
FDA · DevicePhilips North America LlcDevices were distributed to the following US states: FL, ID, NJ, OK, SC and…Official notice →- 2022-04-20
US
Philips North America, LLC recalls The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s:…
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
FDA · DevicePhilips North America, LLCWorldwide distribution: US (nationwide) Including Puerto Rico and OUS…Official notice →- 2022-04-13
US
Philips North America Llc recalls Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063,…
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from…
- 2022-03-16
US
Philips North America Llc recalls Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an…
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room,…
FDA · DevicePhilips North America LlcUS Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark…Official notice →- 2022-02-09
US
Philips North America Llc recalls eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version…
eCareManager (eCM) Sentry Score software not approved for use
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the country of Australia.Official notice →
Other drugs & medical recalls in the United States
- 2022-04-13
US
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to…
FDA · DeviceVolcano CorporationUS: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…Official notice →US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice →US
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice →US
DeRoyal Industries Inc recalls DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the…
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA · DeviceDeRoyal Industries IncUS distribution to Florida, New Jersey, and TennesseeOfficial notice →US
Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
FDA · DeviceHologic, IncUS: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA,…Official notice →US
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP…
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
FDA · DeviceCook Medical IncorporatedUS Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile GuamOfficial notice →