Spacelabs Healthcare, Ltd. recalls
Every recall we track for Spacelabs Healthcare, Ltd. — 6 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
6 recalls since 2017.
All FDA recall records for Spacelabs Healthcare, Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 0 | 0 | 1 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Spacelabs Healthcare, Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Spacelabs Healthcare, Ltd. recalls
5 shown- Lower riskMedical device
Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product
Spacelabs Healthcare recalls Sentinel V11 software version 11.6.0 due to potential patient data mix-ups during admission and testing. Affected units may save data for the wrong patient. No remedy specified in recall notice.
SpacelabsSep 16, 2025 - Lower riskMedical device
Spacelabs Healthcare, Ltd. recalls Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the
Spacelabs recalls model 98700 portable Holter recorders made between April 2021 and November 2024 due to potential mismatch between physical and programmed serial numbers.
SpacelabsNov 25, 2024 - Lower riskMedical device
Spacelabs Healthcare, Ltd. recalls Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is
Spacelabs Healthcare recalls Sentinel V10.x and V11.x models 98200/98201 after system upgrades may add incorrect comments to ECG and blood pressure tests, potentially causing confusion in results.
Spacelabs HealthcareNov 6, 2020 - Use cautionMedical device
Spacelabs Healthcare, Ltd. recalls Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and
Spacelabs Healthcare recalls Arkon Anesthesia Delivery Systems with specific software and display units that may stop working mid-use, risking patient safety. Affected units have unique serial numbers listed in the recall notice.
SpacelabsJul 11, 2018 - Use cautionMedical device
Spacelabs Healthcare, Ltd. recalls Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The
Spacelabs recalls Arkon anesthesia workstations with software version 2.61 due to potential mechanical ventilation failure and blank display without alarms. Affected units may need repair or software update.
SpacelabsOct 11, 2017
Spacelabs Healthcare, Ltd. recall questions
How many recalls has Spacelabs Healthcare, Ltd. had?
6 recalls from Spacelabs Healthcare, Ltd. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Spacelabs Healthcare, Ltd. recall?
Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product, dated Sep 16, 2025. Every Spacelabs Healthcare, Ltd. recall is listed on this page, newest first.
What should I do if I have a recalled Spacelabs Healthcare, Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Spacelabs Healthcare, Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.