Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II A...
FDA Device Recall #Z-0968-2013 — Class I — January 15, 2013
Recall Summary
| Recall Number | Z-0968-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | January 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Del Mar Reynolds Medical, Ltd. |
| Location | Hertford, N/A |
| Product Type | Devices |
| Quantity | 108 total (17 units in the US and 91 units outside the US) |
Product Description
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
Reason for Recall
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Distribution Pattern
Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
Lot / Code Information
serial numbers: ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087. Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated. the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking. Five incorrect serialnumbers were included in the original serial numbers provided to FDA. This was a result of a data entry error. An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013. The correction to the Rest of the World report is as follows: Incorrect SN Reported to FDA Correct, Nonconforming SN ABSO 005883 ABSO-004514 ABSO 005884 ABSO-004515 ABSO 005885 ABSO-004516 ABSO 005886 ABSO-004517 ABSO 005887 ABSO-004518
Other Recalls from Del Mar Reynolds Medical, Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2093-2017 | Class II | Spacelabs Healthcare Arkon Anesthesia Delivery ... | Apr 14, 2017 |
| Z-1460-2017 | Class II | Arkon Anesthesia Delivery System, Model 99999. ... | Feb 8, 2017 |
| Z-1458-2015 | Class II | Spacelabs Pediatric Flow Sensor Kit, PN: 376-05... | Mar 5, 2015 |
| Z-1442-2014 | Class I | SpaceLabs Arkon Anesthesia Delivery System with... | Mar 10, 2014 |
| Z-0352-2014 | Class I | CAS I/II Absorbers that are parts of the Blease... | Oct 17, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.