Phasor Drill units recalled due to reverse battery orientation
Phasor Drill neurosurgical units with reversed battery orientation are being recalled. The recall affects 1,064 units distributed across the United States and U.S. territories.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA device recall with no reported injuries or adverse events. The stated consequence is an increase in surgical time, a functional defect warranting precautionary recall but not meeting criteria for higher severity due to the absence of reported harm.
Plain-English summary
Phasor Health, LLC is recalling 1,064 units of the Phasor Drill, a medical device used in neurosurgical procedures. The affected units may have a reverse battery orientation that may increase surgical time.
The recalled units were distributed to healthcare facilities across the United States and U.S. territories, including Pennsylvania, Indiana, Arizona, Missouri, Louisiana, Florida, Texas, Massachusetts, Ohio, Tennessee, Michigan, West Virginia, Virginia, California, Delaware, New Hampshire, Georgia, South Carolina, New York, New Jersey, Minnesota, Wisconsin, Nebraska, Washington, Illinois, Arkansas, Guam, and Puerto Rico.
Healthcare providers and facilities with affected Phasor Drill units can identify them using the recalled product codes (UDI-DI: B775270S0, B775320L0, B7754500, B7755300, B7756350) and associated lot numbers. Facilities should contact Phasor Health, LLC for further information and guidance regarding the recalled units.
The recalled product
- Product
- Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
- Manufacturer
- Phasor Health, LLC
- Hazard
- battery-orientation
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: B775270S0
- B775320L0
- B7754500
- B7755300
- B7756350. Lot: 241002450
- 241002530
- 241009450
- 241009530
- 241016450
- 241016530
- 241023450
- 241023530
- 241030450
- 241030530
- 24112027S
- 24121827S
- 24122727S
- 25012227S
- 24082832L
- 24102332L
Distribution
Distributed in 29 states:
- AR
- AZ
- CA
- DE
- FL
- GA
- GU
- IL
- IN
- LA
- MA
- MI
- MN
- MO
- NE
- NH
- NJ
- NY
- OH
- PA
- PR
- SC
- TN
- TX
- VA
- VT
- WA
- WI
- WV
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