SPACELABS HEALTHCARE LTD. FDA Inspection Record
SPACELABS HEALTHCARE LTD. is an FDA-registered facility (FEI 3002807992) located in HERTFORD Hertfordshire, GB. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Nov 1, 2017: No Action Indicated (NAI)
- Inspections on record
- 1 (1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 12, latest Sep 16, 2025
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 1, 2017 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 16, 2025 | Class II | Z-0416-2026 | Brand Name: Sentinel V11
Product Name: Sentinel V11
Model/Catalog Number… Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed… |
| Nov 25, 2024 | Class II | Z-0684-2025 | Eclipse PRO REF 98700
The Spacelabs model 98700 is a portable non-invasive Holter… and 1 more product Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial… |
| Nov 6, 2020 | Class II | Z-0563-2021 | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest… During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain… |
| Jul 11, 2018 | Class I | Z-2589-2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly… Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. |
| Oct 11, 2017 | Class I | Z-0072-2018 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit… Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery… |
| Feb 8, 2017 | Class II | Z-1460-2017 | Arkon Anesthesia Delivery System, Model 99999.
Product Usage:
Continuous Ventilator… Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has… |
| Mar 5, 2015 | Class II | Z-1458-2015 | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare… Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the… |
| Mar 10, 2014 | Class I | Z-1442-2014 | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This… The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. |
| Oct 17, 2013 | Class I | Z-0352-2014 | CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the… Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in… |
| Jun 7, 2013 | Class II | Z-1771-2013 | Spacelabs ARKON Anesthesia Workstation.
Spacelabs ARKON Anesthesia Workstation may be… Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a… |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Spacelabs Healthcare, Ltd.
- Location
- HERTFORD Hertfordshire (GB)
- Source
- device