Mobius Imaging, LLC recalls Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Read the official notice →- Date
- 2026-01-21
- Country
- United States
- Brand
- Mobius Imaging
- Product
- Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Mobius Imaging recalls
- 2023-01-25
USMobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider…
FDA · DeviceMobius Imaging, LLCWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice →- 2022-12-07
- US
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the…
FDA · DeviceMobius Imaging, LLCDomestic distribution to consignees in Colorado, Tennessee, and Utah.Official notice →
Other drugs & medical recalls in the United States
- 2026-01-21
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France,…Official notice → - US
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- US
Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX,…Official notice → - US
Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA · DeviceMedicrea InternationalUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Official notice → - US
REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser…
- US
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3…
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FDA · DeviceAbbott Diabetes Care, Inc.U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO,…Official notice →