NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and…
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain…
Read the official notice →- Date
- 2023-07-12
- Country
- United States
- Brand
- NeuroLogica
- Product
- OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia, Canada,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 NeuroLogica recalls
- 2025-11-19
US
NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
FDA · DeviceNeuroLogica CorporationDomestic: US Nationwide Distribution. International: Australia, Belgium,…Official notice →- 2024-08-28
US
NeuroLogica Corporation recalls GM60A. Digital Diagnostic Mobile X-Ray System.
Potential for the anti-fall system of the device arm to fail.
FDA · DeviceNeuroLogica CorporationUS Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO,…Official notice →- 2024-02-21
US
NeuroLogica Corporation recalls Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
FDA · DeviceNeuroLogica CorporationUS Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL,…Official notice →- 2023-04-26
US
NeuroLogica Corporation recalls Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
Other drugs & medical recalls in the United States
- 2023-07-12
US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Storage and Retrieval Module (SRM)
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice →US
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB…
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
US
TEI Biosciences, Inc. recalls PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1),…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice →US
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalls Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
FDA · DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Worldwide distribution - US Nationwide and the countries of Australia, Japan,…Official notice →US
Intuitive Surgical, Inc. recalls da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ,…Official notice →