Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 ...

FDA Device Recall #Z-1734-2019 — Class II — May 6, 2019

Recall Summary

Recall Number Z-1734-2019
Classification Class II — Moderate risk
Date Initiated May 6, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Maquet Cardiovascular Us Sales, Llc
Location Wayne, NJ
Product Type Devices
Quantity U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455

Product Description

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

Reason for Recall

User may suffer an electric shock when coming in contact with the exposed electronic components

Distribution Pattern

Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG KONG HONDURAS HUNGARY ICELAND INDIA IRAN IRELAND ISRAEL ITALY JAPAN JORDAN KUWAIT LATVIA LEBANON LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVA MONTENEGRO MOROCCO MYANMAR NETHERLANDS NAMIBIA NORWAY NEW ZEALAND PAKISTAN PARAGUAY PERU PHILIPPINES POLAND PORTUGAL ROMANIA SAUDI ARABIA SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TURKEY TURKMENISTAN UKRAINE UNITED ARAB EMIRATES URUGUAY UNITED KINGDOM VIETNAM

Lot / Code Information

(1) Part 720001B2 S/N 1 to S/N 416 (2) Part 720001B0 S/N 1 to S/N 1416 (3) Part 720001F2 S/N 1 to S/N 91 (4) Part 720001F0 S/N 1 to S/N 220 (5) Part 710001B2 S/N 1 to S/N 8 (6) Part 710001B0 S//N 1 to S/N 11 (7) Part 710001F0 S/N 1 Expanded lots: 720001B2 SN 417 to SN 503 720001B0 SN 1417 to SN 1689 720001F2 SN 92 to SN 119 720001F0 SN 221 to SN 226 and SN 701 to 711 710001B2 SN 9 to SN 14 710001B0 SN 12 to SN 88

Other Recalls from Maquet Cardiovascular Us Sales, Llc

Recall # Classification Product Date
Z-0632-2021 Class II HLS Set Advanced Model Name: BEQ-HLS 5050 USA; ... Nov 20, 2020
Z-0633-2021 Class II HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS ... Nov 20, 2020
Z-0443-2021 Class II Blood Monitoring Unit (BMU 40), model no. 70104... Sep 30, 2020
Z-0133-2021 Class II Yuno II Mobile Operating Table - Product Usage:... Sep 24, 2020
Z-0132-2021 Class II Yuno Mobile Operating Table - Product Usage: In... Sep 24, 2020

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Maquet Cardiovascular ... Recalls by Firm Recall Reasons Device Safety Stats