28 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FNL·May 19, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
FDA Recall
Open, Classified
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·August 29, 2023
ProCuity bed series, model number 3009, item number: 300900000000,
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·May 12, 2021
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·May 12, 2021
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
FDA Recall
Open, Classified
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·August 29, 2023
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.
FDA Recall
Open, Classified
·Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic·Product code FNL·November 13, 2019
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296. b. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FNL·September 18, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JNL·September 5, 2024
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Recall
Open, Classified
·KAYSERBETTEN GMBH & CO. KG Rieper Str. 12 Bad Fallingbostel Germany·Product code FNL·May 4, 2026
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FNL·May 19, 2023
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCuity bed series, model number 3009, item number: 3009PX-L-200
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNL·August 30, 2023