Leica ARveo and M530 OH6 microscope systems.
Class I - DangerousWhat Should You Do?
- Check if you have this product: M530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Leica Microsystems, Inc.
- Reason for Recall:
- Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Leica ARveo and M530 OH6 microscope systems.
Product Codes/Lot Numbers:
M530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2399-2020
Related Recalls
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Leica Microsystems
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.