115 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·March 5, 2024
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Compella Therapy Air Supply Unit
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·February 14, 2022
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) Centrella Max Surface, REF P7922A02; (3) Centrella Max Surface with X-Ray, REF P7922A03; (4) Centrella Max,Narrow, Rental, REF P7922ARENT01; (5) Centrella Pro+ 36" Surface with X-Ray, REF P7923A01; (6) Centrella Pro+ 40" Surface with X-Ray, REF P7923A02; (7) Centrella Pro+36" Surface, REF P7923A03; (8) Centrella Pro+ 40" Surface, REF P7923A04; (9) Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01; (10) 80" MRS with X-Ray AU/NZ REF P006800A03; (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01; (12) Pro+ MRS Surface for Versacare, REF P3255A02; (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01; (14) Pro+ 36"MRS Surface with X-Ray, REF P7924A01; (15) Pro+ 40" MRS Surface with X-Ray, REF P7924A02; (16) Pro+ 36" MRS Surface, REF P7924A03; (17) Pro+ 40" MRS Surface, REF P7924A04; (18) Pro+ 36" MRS Rental Surface with X-Ray, REF P7924ARENT01.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·May 8, 2024
Compella Bariatric Bed System
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·February 14, 2022
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·October 4, 2023
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·March 31, 2023
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code IOQ·February 25, 2025
Ringed DxI Reaction Vessels (RVs)
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·June 20, 2023
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
FDA Recall
Open, Classified
·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Recall
Open, Classified
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·June 14, 2021
Proteus 235-Proton Therapy System
FDA Recall
Open, Classified
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·May 26, 2021
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Recall
Open, Classified
·Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium·Product code LHN·April 20, 2022
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
FDA Recall
Open, Classified
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·February 15, 2022