Recall Z-1817-2024— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2024-04-01. It names 3 FDA 510(k) clearances: K121623, K113068, K090539. Product: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124. Reason: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-04-01
- Firm location
- Murrysville, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM
- K113068 — REMSTAR AUTO A-FLEX HT
- K090539 — BIPAP AUTOSV ADVANCED
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Reason for recall
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.