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…
Read the official notice →- Date
- 2022-07-06
- Country
- United States
- Brand
- Getinge Usa Sales
- Product
- VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-11-23
USGetinge 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 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…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide and the countries of Australia (AU),…Official notice → - 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 → - 2022-06-29
- 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 → - 2022-06-15
- US
Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice → - 2022-05-25
- US
Getinge Usa Sales Inc recalls Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-13
- US
- 2022-07-06
- US
Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference…
- US
Skytron, Div. The KMW Group, Inc recalls Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.
FDA · DeviceSkytron, Div. The KMW Group, IncWorldwide distribution - US Nationwide and the countries of Canada and Japan.Official notice → - US
K2M, Inc. recalls Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response;…
FDA · DeviceK2M, Inc.Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to…Official notice → - US
Baxter Healthcare Corporation recalls NaviCare Nurse Call/Voalte Nurse Call
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls…
- US
Davol, Inc. recalls HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing,…
The product is not able to provide irrigation.
FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →