Getinge Usa Sales Inc: Device Recall

Recall Details

Recall Number

Z-2271-2024

Classification

Class II

Product Type

Device

Recalling Firm

Getinge Usa Sales Inc

Status

Ongoing

Date Initiated

05/29/2024

Location

Wayne, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

73 units

Reason for Recall

The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.

Product Description

ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

Distribution Pattern

Domestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.

Other Recalls by Getinge Usa Sales Inc

• Class I: Dangerous 01/15/2025
  Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay

View all recalls by Getinge Usa Sales Inc →