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…
Read the official notice →- Date
- 2025-11-12
- Country
- United States
- Brand
- Spacelabs Healthcare
- Product
- Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the state of MN and the countries 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 2026-08-19
USSpacelabs Healthcare, Inc. recalls Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The…
Due to off-the-shelf display port component that has audio/video failures
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →- 2026-05-13
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Spacelabs 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 → - 2025-10-22
- US
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…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - United States Nationwide distribution including in the states 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 →
Other drugs & medical recalls in the United States
- 2025-11-12
- US
Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F…
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for…
- US
Zimmer, Inc. recalls Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number:…
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package…
FDA · DeviceZimmer, Inc.US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS,…Official notice → - US
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Incorrect titanium screw, packaged with dental implant.
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OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
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Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for…
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