Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of…
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- Spacelabs Healthcare
- Product
- Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version:…
- Classification
- Class II
- Units
- Worldwide - United States Nationwide distribution including in the states of…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Spacelabs Healthcare recalls
- 2026-05-13
USSpacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A…
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of…Official notice →- 2026-04-15
- US
Spacelabs Healthcare, Inc. recalls Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide distribution including in the states of NY, NJ, AL,…Official notice → - 2025-11-12
- US
Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description:…
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific…
FDA · DeviceSpacelabs Healthcare, Ltd.Worldwide - US Nationwide distribution in the state of MN and the countries of…Official notice → - 2025-01-15
- US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL,…Official notice → - US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX,…Official notice → - 2024-12-25
- US
Spacelabs Healthcare, Ltd. recalls Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory…
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the…
FDA · DeviceSpacelabs Healthcare, Ltd.U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-22
- US
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution- US Nationwide and the country of Canada.Official notice → - US
Baxter Healthcare Corporation recalls CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
IV sets may leak.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to…
FDA · DeviceAmerican Contract Systems Inc.US Nationwide distribution in the states of SD, IA, MN, WA, IL.Official notice → - US
Philips North America recalls Cardiac Workstation 5000; Model Number: 860439;
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
FDA · DevicePhilips North AmericaUS Nationwide distribution in the states of CA, IA, TN, TX, VA.Official notice → - US
ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds.…
Wound dressing may have foreign matter on the product.
FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL,…Official notice → - US
Fisher & Paykel Healthcare, Ltd. recalls Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user…
FDA · DeviceFisher & Paykel Healthcare, Ltd.US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY,…Official notice →