Getinge Usa Sales Inc recalls Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric…
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be…
Read the official notice →- Date
- 2022-08-31
- Country
- United States
- Brand
- Getinge Usa Sales
- Product
- Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia (AU),…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Getinge Usa Sales recalls
- 2023-02-01
USGetinge Usa Sales Inc recalls Getinge Flow-e Anesthesia System, Part No. 6887900
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and…
FDA · DeviceGetinge Usa Sales IncUS nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ,…Official notice →- 2022-12-14
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.Official notice → - 2022-11-23
- US
Getinge Usa Sales Inc recalls Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN.…Official notice → - 2022-08-31
- US
Getinge Usa Sales Inc recalls Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR…
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech…Official notice → - 2022-07-06
- US
Getinge Usa Sales Inc recalls VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961…
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-06-29
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product…
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being…
FDA · DeviceGetinge Usa Sales IncUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri,…Official notice →
Other drugs & medical recalls in the United States
- 2022-08-31
- US
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…
Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Baxter Healthcare Corporation recalls The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the…
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil,…Official notice → - US
Materialise USA LLC recalls ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
- US
Wright Medical Technology, Inc. recalls Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
An incorrect sizing label was applied to the carton packaging.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal…
Inaccurate Distance and Area measurements with use of Global Stack viewport.
FDA · DeviceGE Healthcare, LLCDistribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA,…Official notice → - US
Nobel Biocare recalls Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
FDA · DeviceNobel BiocareU.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.:…Official notice →