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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recalls |
|---|---|
| Recall Numbers | Z-1817-2024 |
| Risk Class | Class 1 |
| Recall Qty | 12,052 Total |
| Classification Date | 2024-05-23 |
| Recall Link | Recall Link. |
| Notes/Alerts | Systems also included in previous Foam Recalls |
| Recall Reason | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. |
DEVICE
| Manufacturer | Philips Respironics, Inc. |
|---|---|
| Model Names | OmniLab Advanced Plus |
| Model Numbers | 1111122, 1111123, 1111124, 1111125, 1111126, 1111127, 1111138, 1111141, 1111142, KR1111127, R1111122, R1111123, R1111124, U1111122, U1111124 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Ventilator, continuous, non-life-supporting |
| Serial Number(s) | +12,000 |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
1. Firm notified customers through mailed letter “URGENT Medical Device Recall” on April 1, 2024. The letter described the product, problem and actions to be taken.
2. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that:
1. The device is appropriately set for patient requirements.
2. Alternate ventilation equipment is available.
3. Alternative monitoring is used where appropriate.
3. Depending on the level of ventilatory support required, customers were advised to place patients on an alternate source of ventilation.
4. Philips is currently investigating the issue. If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Philips Respironics. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
