SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible…
Read the official notice →- Date
- 2025-10-29
- Country
- United States
- Brand
- Sedecal
- Product
- MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
- Classification
- Class II
- Units
- US: CA, IL, and NJ
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Sedecal recalls
- 2024-05-08
US
SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt;…
Potential interference with the anti-fall system.
FDA · DeviceSEDECAL SAWorldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas…Official notice →- 2024-02-21
US
SEDECAL SA recalls MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine…
FDA · DeviceSEDECAL SAUS Nationwide distribution. There was government distribution but no military…Official notice →- 2024-01-31
US
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take…
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA · DeviceSEDECAL SADistribution was made to AL, FL, and NC. There was no military/government…Official notice →- 2023-07-05
US
SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
There is a software login in issue that may prevent the user from logging in.
FDA · DeviceSEDECAL SADistribution throughout United States including Puerto Rico and US Virgin…Official notice →- 2023-03-08
US
SEDECAL SA recalls Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- 2022-11-16
US
SEDECAL SA recalls Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Due to un-commanded movement of mobile x-ray unit.
FDA · DeviceSEDECAL SAU.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY,…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-29
US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in…
US
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
US
HeartSine Technologies Ltd recalls HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution. Worldwide distribution to Argentina, Australia,…Official notice →US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India,…Official notice →US
Becton Dickinson & Co. recalls BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of…
FDA · DeviceBecton Dickinson & Co.Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria,…Official notice →US
Medline Industries, LP recalls Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.