Algete, Spain
SEDECAL SA recalls
7 recalls recorded since 2018, most recently on 10 June 2025. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)7
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 June 2025
- Reason
- 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 consequences of improper cleaning.
- Distribution
- US: CA, IL, and NJ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0243-2026, Z-0255-2026, Z-0248-2026, Z-0270-2026, Z-0277-2026, Z-0271-2026, Z-0284-2026, Z-0287-2026, Z-0254-2026, Z-0283-2026, Z-0278-2026, Z-0245-2026 and 34 more
- MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
- Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
- Model Number 40KWFXPLUS.004, Mobile X-ray system
- Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
- Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
- Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- SM_40HF_B_D_VIR3, Mobile X-ray system
- SM_40HF_BDC3, Mobile X-ray system
- and 38 more product lines
Ongoing Class II Medical devices
- Recall started
- 22 January 2024
- Reason
- Potential interference with the anti-fall system.
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1754-2024
- 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; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30
Ongoing Class II Medical devices
- Recall started
- 13 December 2023
- Reason
- Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
- Distribution
- Distribution was made to AL, FL, and NC. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0781-2024
- 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 exposures of patients in standing, sitting, or laying position.
Ongoing Class II Medical devices
- Recall started
- 23 May 2023
- Reason
- There is a software login in issue that may prevent the user from logging in.
- Distribution
- Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, E
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2045-2023
- wDR 2.2 Mobile Digital Diagnostic X-Ray System
Ongoing Class II Medical devices
- Recall started
- 6 February 2023
- Reason
- Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- Distribution
- US, Argentina, Panama
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1203-2023, Z-1202-2023
- Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
- Phoenix mKDR, digital mobile diagnostic x-ray system
Ongoing Class II Medical devices
- Recall started
- 12 August 2022
- Reason
- Due to un-commanded movement of mobile x-ray unit.
- Distribution
- U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0182-2023
- Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Ongoing Class II Medical devices
- Recall started
- 14 October 2021
- Reason
- 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 positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
- Distribution
- US Nationwide distribution. There was government distribution but no military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1083-2024
- MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.