FDA Device Recall Z-0042-2017: Trumpf Medical Systems, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-2017.

Recall Res Number

Z-0042-2017

Recalling Firm / Manufacturer

Trumpf Medical Systems, Inc.

FEI Number

3003184737

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-07-10

Date Posted

2016-10-05

Date Terminated

2017-03-02

Product Code

JEA

Event Number

75115

Product Quantity

84 units

Product Description Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

Reason for Recall Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Action Details Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.

Distribution Pattern Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Code Information / Serial Numbers Serial Numbers - 101900011, 101900018, 101904491, 101904998

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Black Forest Medical GmbH Registration: 3003923584 View Registration
KANGHUI MEDICAL TECHNOLOGY (SUZHOU) CO.,LTD Registration: 3007031002 View Registration
Baxter Medical Systems GmbH + Co. KG Registration: 3007143268 View Registration
UOC USA Inc. Registration: 3009760038 View Registration
Gabriel Scientific OU Registration: 3010890274 View Registration
AMERICAN SURGICAL SPECIALTIES COMPANY Registration: 3011111237 View Registration
UNITED ORTHOPEDIC CORPORATION Registration: 3012329926 View Registration
SURGIX MEDICAL LLC Registration: 3012995405 View Registration
NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3013522950 View Registration
Baxter Medical Systems (Suzhou) Co. Ltd Registration: 3013836619 View Registration
GALAXY INDIA Registration: 3015223105 View Registration
Paras Surgico Factory Registration: 3027847726 View Registration
GETINGE AB Registration: 3031563141 View Registration
TECNOCIRURGICA COMERCIO DE MATERIAIS MEDICOS CIRURGICOS E HOSPITALARES LTDA Registration: 3043007473 View Registration
MAQUET GMBH Registration: 8010652 View Registration
BRAINLAB SE Registration: 8043933 View Registration
UNITED POLY ENGINEERING PVT. LTD. Registration: 9680168 View Registration
UNITED ORTHOPEDIC CORP. Registration: 9681642 View Registration

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Medical Device Recall: Z-0042-2017

Recall Parameters & Description

Related Establishments / Registrations

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