Z-1126-2015Class II

BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

Name: Z-1126-2015 BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Creator: CME America, LLC
Published: 2015-01-16
License: https://open.fda.gov/license/

CME America, LLC / initiated 2015-01-16 / Terminated / root cause: software

FDA source

CME America, LLC began a recall of BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP on 2015-01-16. FDA classified it as Class II and gives the reason as "CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1126-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Posted: 2015-02-19
Terminated: 2017-03-31
Recalling firm: CME America, LLC
Product: BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Product code: FRN Pump, Infusion
Reason for recall: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Root cause tag: software
FDA root cause: Software design
Action: CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volume (translated into meg or mg). Follow-up Actions by CME America: CME America has identified the root cause of this issue and is recommending installation of a new version of software, USA36B4, for affected BodyGuard 323 infusion pumps. This software is identical to the previously released version, USA36A4.2. However the designation of B4 in the software name will identify updated software in each device. CME America will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Your assistance is appreciated and necessary to prevent use and facilitate remediation of the recalled product. CME America can address any questions regarding the recalled product by calling the CME America recall line at 720-839-2391.
Quantity in commerce: 3,186
Distribution: Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
Product codes and lots: All product with USA36A4.4 version of software affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1126-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-19

Product code FRN

K042696Class IIBodyguard Infusion Pump SystemCaesarea Medical Electronics , Ltd. / cleared 2005-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)