FDAJune 27, 2017device
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipm...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
What to do
FDA enforcement status: Terminated
Brands named
novadaq technologiesnovadaq
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
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