Bed, Ac-powered Adjustable Hospital
General Hospital · 21 CFR 880.5100
Recent MDR events
93,774 adverse event reports on file
- G5510 BED FULL ELECTRICJul 31, 2026DeathInvamex9616091-2026-00006
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08053
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12118
- TotalCare BedJul 31, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01751
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12233
- Centrella BedJul 31, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01752
- Progressa Bed SystemJul 31, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01750
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12292
- TotalCare BedJul 31, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01753
- VersaCare Med Surg BedJul 31, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01755
Event type breakdown
Recalls
155 recall events for this product code
- KAYSERBETTEN GMBH & CO. KGOpen, ClassifiedJun 4, 2026
Pediatric care bed;
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
Z-2212-2026 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 25, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304,
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
Z-0228-2025 · View FDA record ↗ - ARJOHUNTLEIGH POLSKA Sp. z.o.o.Open, ClassifiedDec 22, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with I
Unintended movement of bed wheels
Z-0611-2024 · View FDA record ↗ - ARJOHUNTLEIGH POLSKA Sp. z.o.o.Open, ClassifiedDec 22, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with I
Unintended movement of bed wheels
Z-0612-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 300900000000,
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0424-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0425-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0426-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0427-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0428-2024 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 1, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0429-2024 · View FDA record ↗
Registered firms
236 firms currently registered for this product code
Agiliti Health - Milwaukee
Wauwatosa, WI, US
Hill-rom, Inc.
Batesville, IN, US
Tfc Technology Co., Ltd.
Jiaxing Zhejiang, CN
Tr Group, Inc.
Rockford, IL, US
Hosmed Inc.
Doral, FL, US
Rong Shin Industrial Co., Ltd.
Tainan City, TW
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Guangdong Kangshen Medical Technology Co.,ltd.
ZHAOQING Guangdong, CN
Jiangmen Jia Mei Medical Products Co., Ltd.
Heshan City Guangdong, CN
Huangshan Jinfu Medical Equipment Co., Ltd.
Huangshan City Anhui, CN
J. Sterling Industries Ltd.
Woodbridge Ontario, CA
Taiwan Diversitec Manufacturing Corp.
Taoyuan, TW
Human Care Usa, Inc.
AUSTIN, TX, US
Accora Ltd
Royston Hertfordshire, GB
Paramount Bed Co., Ltd.
Koto-ku Tokyo, JP
Zhongshan Sunneo Medical Instruments Co.,ltd
Zhongshan Guangdong, CN
Foshan Shenyu Medical Equipment Co., Ltd.
Foshan City Guangdong, CN
Rehab Italian Design Co., Ltd.
Ho Chi Minh City, VN
Sigma-care Development Co., Ltd.
Dalin Township, Chiayi County, TW
Innovative Sleep Technologies
Saint Peters, MO, US
Joerns Healthcare Matamoros
H. Matamoros, Tamaulipas Mexico, MX
Hubei Yinkang Medical Equipment Co., Ltd
Xiaogan Hubei, CN
Advanced Instrumentations, Inc.
Miami, FL, US
Cognate India
NEW DELHI, IN
Kap Medical
CORONA, CA, US
510(k) clearances
70 clearances for this product code
- Stryker CorporationJun 18, 2021
K202964 · iBed Wireless with iBed Mobile
- Stryker CorporationDec 16, 2010
K103536 · IBED WIRELESS WITH IBED AWARENESS
- Vail Products, Inc.Oct 5, 1998
K982783 · VAIL 1000 ENCLOSED BED
- Invacare Corp.Jan 6, 1998
K974296 · MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
- M.C. Healthcare Products, Inc.Dec 16, 1997
K974254 · BENEFIT B3--- SERIES
- Volker Healthcare, Inc.Aug 29, 1997
K972115 · VOLKER HOSPITAL BED, MODEL K960
- Nova Technologies, Inc.Jul 10, 1997
K971546 · SOMA 900 TRANSPORT BED
- Vail Products, Inc.May 7, 1997
K963622 · VAIL 2000 ENCLOSED BED